MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60AC

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

A sample was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure after the surgeon placed the lens in the patient's eye, he noticed that the lens would not center.The lens was removed and the patient was left aphakic.The doctor plans to implant another iol in the future.Additional information was requested.

Manufacturer Narrative

The lens was returned in the lens case.A small amount of viscoelastic was observed.No lens damage was observed.The lens dimensions (plan view) are acceptable using an approved template.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported "decentered" lens could not be determined.The manufacturer internal reference number is: (b)(4).

Event Description

In a follow up the surgeon explained that during surgery, due to patient's history of unhealthy cornea becoming hazy and patient being (b)(6) and restless, it was difficult for him to assess why the lens would not center.After he retrieved the lens, he decided it was best to leave the patient aphakic and possibly consider a secondary iol in the future.There was no fault seen with the iol once he removed and examined it outside of the eye.The patient's prognosis is fair.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8282277
• MDR Text Key: 134243424
• Report Number: 1119421-2019-00105
• 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,o
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.245
• Device Lot Number: 12476397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISCOVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR