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

Model Number SA60AT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Prolapse (2475)

Event Date 09/13/2018

Event Type  Injury  

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 similar complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a complicated cataract extraction with intraocular lens (iol) implant procedure, the anterior chamber became unstable due to iris prolapse.The iol was removed and will be replaced once the eye condition is stable.Additional information was provided that the iol was exchanged during the initial procedure.The patient stayed in the hospital overnight and was discharged the next day.

Manufacturer Narrative

Product evaluation: the iol was returned for analysis.Additional observations were as follows: iol returned positioned correctly in the case.Solution is dried on both surfaces of the optic and haptics.No damage observed to the iol.The root cause for the reported complaint "unstable anterior chamber" could not be determined.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.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
• MDR Report Key: 8042693
• MDR Text Key: 126350625
• Report Number: 9612169-2018-00154
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.230
• Device Lot Number: 21182170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other