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

Model Number SA60AT

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Failure of Implant (1924)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

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 health care professional reported that during an intraocular lens (iol) implant procedure the lens entered the eye broken because the haptic remained trapped in the injector.The lens was removed from the patient's eye and a replacement lens was implanted with no harm to the patient.Additional information has been requested.

Manufacturer Narrative

The product was returned for analysis and damage was observed to the iol.No cartridge was returned.Additional observations were as follows: an empty iol case returned.Iol returned wrapped in an adhesive tape.Iol cannot be removed from the tape as it's glued from both sides.No evaluation can be performed.It is visable that iol is cut in half.One haptic is broken/torn and not returned.No cartridge/injector was returned.The product investigation could not identify the root cause for the reported complaint as only the iol was returned for evaluation.No cartridge/injector was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The reported complaint is lacking in relevant information such as viscoelastic used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.The dimensions of the lens could not be tested due to the condition of the returned sample.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: 11349242
• MDR Text Key: 234283559
• Report Number: 9612169-2021-00041
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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 Model Number: SA60AT
• Device Catalogue Number: SA60AT.120
• Device Lot Number: 21276134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III C CARTRIDGE