MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60AT

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Date 10/07/2019

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.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, "the surgeon implanted the iol and it did not open in the patient's eye." additional information has been requested.

Manufacturer Narrative

Additional information provided in a1., a.2., a.3., and b.3.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in a1, a2, a3, h6 and h10 returned videos show three iols, each iol is shaken out of the lens case on a table.The lenses appear to be used.Ovd is observed dried on the lenses.Three returned photos were provided showing iols outside the lens case.All three iols appear to have ovd dried on.Reported complaint cannot be confirmed from the returned photos/videos.No determination can be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.

Manufacturer Narrative

The product was returned for analysis and the reported complaint could not be confirmed.Iol returned mangled in lens case.Solution is dried on both surfaces of the optic and haptics.One haptic tip is broken/torn and not returned, the other haptic is bent deformed.The optic is punctured by a lens case post and is fractured, bent and scratched/marked-rejectable.Unable to perform fold test due to the condition of the returned sample.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 10511386
• MDR Text Key: 207135284
• Report Number: 9612169-2020-00189
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 21239504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female