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

Model Number SA60AT

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been one other complaint reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported an intraocular lens (iol), "was warped when placed in the eye".The procedure was completed the same day.Additional information was requested.

Manufacturer Narrative

The lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.One haptic is bent in the haptic/optic junction area, which may have been interpreted as the reported complaint of "warped".The optic edge is nick/chipped.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of an unspecified viscoelastic.It is unknown if qualified products were used.One haptic is bent in the haptic/optic junction area, which may have been interpreted as the reported complaint of "warped".Other lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 9425851
• MDR Text Key: 176230075
• Report Number: 1119421-2019-02067
• 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: 02/20/2020

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: 05/31/2024
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.200
• Device Lot Number: 12718198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED VISCOELASTIC