Recall Z-1606-2024 ยท LRO General Surgery Tray
Alcon Research, LLC
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF
| Date | Apr 22, 2024 (initiated Mar 15, 2024) |
| Status | Open, Classified |
| Reason | Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. |
| Root cause | Under Investigation by firm |
| Action | On 03/15/2024, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION" Letter via FedEx overnight to inform customer that, specific lots of Alcon Custom Pak containing Oasis Medical 27G Chang Hydrodissection Cannulas. Alcon has received customer complaints for foreign material, occlusions and bent tips for these cannulas. We are asking that you remove and dispose of the included 27G Chang Hydrodissection Cannula upon opening your Custom Pak for its specific surgical case. Customer are to take the following actions: 1. See Table 1 for list of affected Alcon Custom Pak lots that we |
| Quantity | 57,352 cannulas |
| Distribution | Worldwide distribution - U.S. Nationwide including in the states of AK, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Australia, Canada, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |