Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 18, 2017
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of S…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bausch & Lomb, Inc. recalled Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical pro… - a moderate-severity action.
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical pro… was recalled by Bausch & Lomb, Inc. in January 18, 2017. Reason: According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he h…. Check the official notice for the remedy. Verify recall #Z-0983-2017 with the FDA Devices before acting.
The recall
Bausch & Lomb, Inc. issued this moderate-severity FDA Devices recall-According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he h….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- January 18, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0983-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0983-2017) was formally reported on January 18, 2017, with the manufacturer initiating the action on October 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Bausch & Lomb, Inc. is listed as the recalling firm, operating out of Lynchburg, VA. Federal records list the affected scope as 2487 units Domestic (USA), 1,211 units Foreign (outside USA).
The documented reason for this recall is: According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2487 units Domestic (USA), 1,211 units Foreign (outside USA)
Related Recalls
6
3 from same agency
Product description
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
Reason for recall
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0983-2017 |
| Date reported | January 18, 2017 |
| Date initiated | October 12, 2016 |
| Recalling firm | Bausch & Lomb, Inc. |
| Firm location | Lynchburg, VA |
| Affected scope | 2487 units Domestic (USA), 1,211 units Foreign (outside USA) |
| Distribution | Worldwide Distribution - US Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0983-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient. Recalled by Bausch & Lomb, Inc.. Units affected: 2487 units Domestic (USA), 1,211 units Foreign (outside USA).
Why was this product recalled? ▼
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0983-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0983-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 18, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.