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

Model Number MA60BM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Visual Impairment (2138)

Event Date 06/14/2022

Event Type  Injury  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that following cataract surgery with intraocular lens (iol) implant procedure patient experienced decreased visual acuity after surgery and was considered to be due to glistening/ssng.The iol exchanged for another non company lens 26 years following the initial procedure.Additional information has been requested.

Manufacturer Narrative

The lens was returned for evaluation.Solution is dried on the lens.The optic is cut across one of the haptic insertion areas to the center of the optic.This cut is typical of lens removal from the eye.The welded area of the haptic is out of the optic due to the lens being split across the haptic.Large marks matching on both the anterior and posterior sides of the optic that are in the shape of a surgical instrument used to grasp the lens are visible.Scrape marks are observed on the optic.The optic appears to be clear other than the observed damage.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.Lens damage was observed.The optic appears to be clear other than the observed damage.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been requested and received stating although the corrected visual acuity was unchanged before and after the replacement surgery, the blurred vision and glare, which could not be removed by wearing scl before the surgery, disappeared after the surgery, so it is thought that the glistening and whitening of the iol were the cause.

Manufacturer Narrative

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: 15779098
• MDR Text Key: 303561350
• Report Number: 1119421-2022-02397
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2023

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 Model Number: MA60BM
• Device Catalogue Number: MA60BM.130
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/14/2022; 12/21/2022
• Supplement Dates FDA Received: 12/12/2022; 01/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 77 YR
• Patient Sex: Male