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

Model Number MA30BA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Event Description

A non-healthcare reported that following an intraocular lens (iol) implant procedure, the lens was explanted after 25 years of initial implantation for an unknown reason.Additional information was received stating that after 25 years, the patient was experiencing so much flare of light that an iol was exchanged.The iol had vac and nano glistening's (white outer edge of iol).

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Pieces of the lens were returned in a clear water-like liquid inside a specimen cup.Both haptics were in the haptic insertion area (only one broken haptic portion was returned).The optic was torn/split/cracked and cut into multiple pieces, typical of insertion and removal.Both cut optic portions had multiple scratches and scuff marks on the anterior.And posterior sides of the lens in the shape of an instrument used to grasp the lens.The damage observed, is typical of insertion and removal of the lens.Power and resolution testing was attempted.Exact focal length/resolution measurements could not be obtained, due to the extensive optic damage.The lens pieces were removed from the clear water-like liquid and was allowed to dry.Upon drying the lens appears clear.The root cause for the reported events could not be determined.The lens was retuned torn/split/cracked and cut into multiple pieces.Power and resolution testing was attempted.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14346605
• MDR Text Key: 291299380
• Report Number: 1119421-2022-00990
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2001
• Device Model Number: MA30BA
• Device Catalogue Number: MA30BA.245
• Device Lot Number: 410553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/1996
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female