FDA Medical Device Recalls (openFDA)
Alcon Research, LLC: Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
- Recall number
- Z-1373-2022
- Recalling firm
- Alcon Research, LLC
- Product
- Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS
- Status
- Open, Classified
- Initiated
- 2022-06-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
- Root cause
- Process control
- Action
- On 06/09/2022, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL" Letter via overnight mail to customer informing them that specific lots of Alcon Custom Paks were manufactured containing latex gloves and were intended to contain non-latex gloves. Customers are instructed to: 1. Review your inventory to determine if you have any unused affected product within your facility. See Table above for affected Custom Pak. 2. Segregate any unused affected product from your inventory. 3. An Alcon associate will reach out to you directly to arrange for the return and replacement of your affected inventory of Alcon Custom Pak. 4. Fill out the attached Response Form , even if you have zero (0) units remaining in inventory and return the form to Alcon using the contact information provided on the form. 5. Please forward this information to: " all departments within your organization who may be in possession of this affected product; and " any other organization to which this product may have been transferred. For questions - contact Alcon Customer Service at 1-800-862-5266
- Quantity
- 320 kits
- Distribution
- U.S.: AZ, CA, MO, and NY O.U.S.: None
- Lot, serial or model codes
- Pak #/Batch # / UDI Code 16998-11 / 2519351H / (01)10380651677385(10)2519351H(17)230331(30)3 18392-03 / 14HDFF / (01)10380651665238(10)14HDFF(17)221231(30)4 18527-03 / 14JM57 / (01)10380651684406(10)14JM57(17)240630(30)5 11802-07 / 14KFAF / (01)10380653423096(10)14KFAF(17)240430(30)5 11802-07 / 14LTRW / (01)10380653423096(10)14LTRW(17)240430(30)5 11802-07 / 14LLME / (01)10380653423096(10)14LLME(17)240430(30)5 14429-07 / 14HPW3 / (01)10380651666433(10)14HPW3(17)240229(30)6
- 510(k) numbers
- ["K880961"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1000117501
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28