Alcon Custom Pak Surgical Procedure Pack

FDA device recall Z-0354-2023 · posted 2022-12-01 · Open, Classified

Recall details

Recalling firm

Alcon Research, LLC

Reason for recall

Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

Action taken

On 10/31/2022, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION" Letter via overnight mail informing customers about the problem, the product and the actions to be taken. Customers are instructed to: 1. See table 1 for list of affected Alcon Custom Pak lots (included in list) that were distributed to their facility. They may receive Custom Pak lots assembled prior to this Field Correction notification, and as a result, may be receiving affected inventory in future shipments. If they receive any affected lots in the future, they will be identified by a sticker. The stickers will state (in red print) "URGENT FIELD CORRECTION Discard enclosed 3M surgical drape. Replace with sterile standalone drape." 2. Review inventory of Alcon Custom Pak lots against the attached table. For affected lots of Custom Pak in their inventory, affix the provided stickers directly to the outside of the identified affected Custom Pak units in a location most easily seen for their facility. NOTE: Alcon Custom Pak units and standalone drapes are sterile and should not be opened prior to surgery. 3. For current on-hand affected inventory, upon opening of your identified Alcon Custom Pak for surgical use, remove and dispose of the enclosed 3M Steri-Drape Surgical Drape. Call Alcon Customer Service (1-800-862-5266) in obtaining replacement sterile standalone drapes. 4. For impacted Custom Pak inventory that will ship in the future, Alcon is planning to ship sterile stand-alone substitutions. 5. Keep Table 1 for their records should they receive any affected Alcon Custom Pak lots in the near future. For questions, contact Alcon Customer Service at 1-800-862-5266

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LRO

Quantity affected

308,610 kits

Distribution

Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, P

Date initiated

2022-10-31

Date posted

2022-12-01

Location

Houston, TX

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