MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60WF

Device Problem Structural Problem (2506)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, when folding the lens, it felt brittle and also had a weird curl on the middle of the lens.There was no patient contact and the procedure was completed with a new lens.Additional information was requested.

Manufacturer Narrative

Product evaluation: the lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.The optic edge has two areas that have small gouged damaged.The posterior surface of the optic has scratches.The reported "curl" shape was not observed.The lens was cleaned with lphse to further assess.The lens did not appear to be brittle.The optic and the haptics are pliable when manipulated.A fold test was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.The product investigation could not identify a root cause for the complaint of "when folding lens, it felt brittle; also had a weird curl on the middle of lens".The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8707896
• MDR Text Key: 148647331
• Report Number: 1119421-2019-00944
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.225
• Device Lot Number: 12609091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1