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

Model Number MA60BM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Literature citation: veshesh patel et.Al., intraocular lens exchange: indications, comparative outcomes by technique, and complications: clinical ophthalmology 23mar2023:17 941¿951.The manufacturer internal reference number is: (b)(4).

Event Description

An other health care professional published original article with a purpose to describe the indications, outcomes, and complications associated with intraocular lens (iol) exchange.Iol exchange was performed in 511 eyes of 489 patients (59.7% men; mean age: 67.0 ± 13.9 years, median time from cataract procedure to iol exchange: 47.5 months).Mean uncorrected visual acuity significantly improved from 20/192 snellen equivalent (logmar 0.981) preoperatively to 20/61 (logmar 0.487) at last follow-up (p < 0.001).Overall, 384 eyes (78.7%) met their desired refractive outcome within ±1.0 diopter (d).The study was concluded stating the iol exchange significantly improved uncorrected visual acuity and more than three-quarters of eyes met the refractive goal.Certain techniques were associated with complications, including subsequent dislocation associated with iris-sutured technique and iol tilt associated with yamane scleral-fixation technique.This information may help guide surgeons in deciding between procedural techniques for individual patients during iol exchange preoperative planning. this file is related to patient who had previous iol exchanged with company lens using iris-sutured technique with suture.The lens was exchanged in re-operation after 63 days from the initial exchange due to dislocation using 4-point scleral sutured technique.The lens was replaced with non company lens.There were 12 files associated with this file, this is 2 of 12 files.Literature citation: veshesh patel et.Al., intraocular lens exchange: indications, comparative outcomes by technique, and complications: clinical ophthalmology 23mar2023:17 941¿951.

• 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: 17069394
• MDR Text Key: 316586641
• Report Number: 1119421-2023-01030
• 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
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60BM
• Device Catalogue Number: MA60BM.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 49 YR