Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 25, 2016
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alcon Research, Ltd. recalled LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refrac… - a moderate-severity action.
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refrac… was recalled by Alcon Research, Ltd. in May 25, 2016. Reason: Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving repor…. Check the official notice for the remedy. Verify recall #Z-1688-2016 with the FDA Devices before acting.
The recall
Alcon Research, Ltd. issued this moderate-severity FDA Devices recall-Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving repor….
- Moderate
- severity level
- 81 units
- affected scope
- Class II
- classification
- May 25, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1688-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1688-2016) was formally reported on May 25, 2016, with the manufacturer initiating the action on April 14, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Alcon Research, Ltd. is listed as the recalling firm, operating out of Fort Worth, TX. Federal records list the affected scope as 81 units.
The documented reason for this recall is: Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut. Distribution data in the federal record shows the product reached: United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine. 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
81 units
Related Recalls
6
3 from same agency
Product description
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Reason for recall
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1688-2016 |
| Date reported | May 25, 2016 |
| Date initiated | April 14, 2016 |
| Recalling firm | Alcon Research, Ltd. |
| Firm location | Fort Worth, TX |
| Affected scope | 81 units |
| Distribution | United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine |
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-1688-2016) 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? ▼
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.. Recalled by Alcon Research, Ltd.. Units affected: 81 units.
Why was this product recalled? ▼
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2016. Severity: Moderate. Recall number: Z-1688-2016.
Where was the recalled product distributed? ▼
Distribution: United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1688-2016) 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 May 25, 2016. 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.