Z-1373-2022Class II

Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03...

Name: Z-1373-2022 Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03...
Creator: Alcon Research, LLC
Published: 2022-06-09
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2022-06-09 / Open, Classified / root cause: manufacturing process

FDA source

Alcon Research, LLC began a recall of Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE... on 2022-06-09. FDA classified it as Class II and gives the reason as "Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1373-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-09
Posted: 2022-07-12
Recalling firm: Alcon Laboratories
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
Product code: LRO General Surgery Tray
Reason for recall: Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
Root cause tag: manufacturing process
FDA 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 in commerce: 320 kits
Distribution: U.S.: AZ, CA, MO, and NY O.U.S.: None
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1373-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1373-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code LRO

K880961Class IIAlcon Surgical Procedure PacksAlcon Laboratories / cleared 1988-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)