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

Model Number SN60AT

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A pharmacist reported that during an intraocular lens (iol) implant procedure, the iol was implanted but zonular weakness could not support the weight of the lens and this went back into the vitreous.During the surgery the patient had disinsertion of the capsular bag, so it was removed and it is decided to implant a lens of fixation in the groove in a second time, surgery from 20 days to 1 month.Additional information has been requested.

Manufacturer Narrative

The corrected/additional information provided by the reporter, indicates that the event was not associated with the device, but due to a pre-existing patient condition.If this additional information had been received prior to the initial report then the event would not have been reportable to the fda.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided by the reporter, who reported that they did not report the case to the health authority because it did not apply as a serious adverse event associated with the device, but a pre-existing patient condition.

Manufacturer Narrative

Evaluation summary: medical review was performed by a company representative: in this case, the patient already had zonular weakness, which failed to support inserted iol, by staying in the capsular bag, as intended.Therefore, the most likely cause of the event was patient related factor (pre-existing anatomy condition).The root cause was determined to be a coincidental event related to patient condition (pre-existing anatomy condition).A malfunction has not been indicated or information provided that the lens was the cause of the event.Based on this information, the device did not cause/contribute to the event.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: 8831393
• MDR Text Key: 152347168
• Report Number: 9612169-2019-00226
• 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,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.235
• Device Lot Number: 21235845
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 08/14/2019; 10/23/2019
• Supplement Dates FDA Received: 09/06/2019; 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention