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

Model Number SA60AT

Device Problem Structural Problem (2506)

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

Event Date 11/20/2019

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 have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A customer reported an intraocular lens (iol) had a fold in it.There was patient contact but no reported patient impact.Additional information was requested.

Manufacturer Narrative

Additional information provided in b.5., d.10., g.1., g.2., h.3., h.6., and h.10.The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.One haptic was bent in the gusset and distal area pressed against the well area of the lens case.The other haptic is broken in the gusset area (not returned).The lens was cleaned with lphse for further evaluation.The optic was leaning against the posts and pressed down into the well area of the lens case.The optic has a small crack near the center of the lens and deep scrape marks near the edge of the lens.A fold inspection was conducted using folding tweezers.The lens unfolded with no abnormalities observed.All product and batch history records are quality reviewed prior to product release.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The report of "fold in middle of lens" wasn't clarified.The lens was foldable using folding tweezers and unfolded with no abnormalities observed.Haptic and optic 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, blood, and the condition of the returned sample, the damage is most likely related to customer handling.The cartridge was not returned for evaluation.It is unknown if a qualified viscoelastic was used.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received reports the fold was created during the loading process.

• 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: 9452493
• MDR Text Key: 176558609
• Report Number: 1119421-2019-02127
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.210
• Device Lot Number: 12683752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1