Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 9, 2014
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alcon Research, Ltd. recalled Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 con… - a moderate-severity action.
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 con… was recalled by Alcon Research, Ltd. in July 9, 2014. Reason: Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains…. Check the official notice for the remedy. Verify recall #Z-1947-2014 with the FDA Devices before acting.
The recall
Alcon Research, Ltd. issued this moderate-severity FDA Devices recall-Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains….
- Moderate
- severity level
- Class II
- classification
- July 9, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1947-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1947-2014) was formally reported on July 9, 2014, with the manufacturer initiating the action on May 16, 2014. 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 684 total (525 units in US).
The documented reason for this recall is: Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle Distribution data in the federal record shows the product reached: Nationwide Distribution including North Carolina and Maine. 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
684 total (525 units in US)
Related Recalls
6
3 from same agency
Product description
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Reason for recall
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1947-2014 |
| Date reported | July 9, 2014 |
| Date initiated | May 16, 2014 |
| Recalling firm | Alcon Research, Ltd. |
| Firm location | Fort Worth, TX |
| Affected scope | 684 total (525 units in US) |
| Distribution | Nationwide Distribution including North Carolina and Maine |
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-1947-2014) 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? ▼
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.. Recalled by Alcon Research, Ltd.. Units affected: 684 total (525 units in US).
Why was this product recalled? ▼
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1947-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including North Carolina and Maine.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1947-2014) 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 July 9, 2014. 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.