Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Pak

FDA device recall Z-1606-2024 · posted 2024-04-22 · Open, Classified

Recall details

Recalling firm

Alcon Research, LLC

Reason for recall

Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.

Action taken

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 were distributed to their facility. They may have received Custom Pak lots assembled prior to this Field Correction notification, and as a result, they may be receiving affected inventory in future shipments. Any affected Alcon Custom Pak in the future, will be identified by a sticker and reads, "URGENT FIELD CORRECTION Discard enclosed 27G Chang Hydrodissection Cannula" 2. Review their inventory of Alcon Custom Pak lots against the lots listed in Table 1. For affected lots in their current on-hand inventory, affix the provided stickers directly to the outside of their affected Custom Pak in a location most easily seen. NOTE: Alcon Custom Pak units are sterile and should not be opened prior to surgery. 3. Upon opening of the identified Alcon Custom Pak for surgical use, remove and dispose of the enclosed 27G Chang Hydrodissection Cannula. 4. Use a separate sterile standalone hydrodissection cannula, either from their own inventory or those supplied by Alcon. For impacted products that will ship in the future, Alcon is planning to ship sterile stand-alone substitutions. Call Alcon Customer Service (1-800-862-5266) if help it needed in obtaining replacement sterile standalone hydrodissection cannulas. 5. Keep Table 1 for their records should they receive any affected Alcon Custom Pak lots in the near future. Questions/concerns, contact Alcon Customer Service at 1-800-862-5266.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LRO

Quantity affected

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,

Date initiated

2024-03-15

Date posted

2024-04-22

Location

Houston, TX

Related 510(k) clearances