MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number MTA3U0

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 records could not be reviewed because the literature report did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Literature citation: patel v, 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 anterior chamber intraocular lens (aciol).The lens was exchanged in re-operation after 1127 days from the initial exchange due to dislocation using aciol technique.The lens was replaced with another company lens.There were no sutures used.There were 12 files associated with this report.This is 10 of 12.Literature citation: patel v, et.Al., intraocular lens exchange: indications, comparative outcomes by technique, and complications:  clinical ophthalmology 23mar2023:17 941¿951.

Manufacturer Narrative

The product was not returned.Complaint history and product history records could not be reviewed because the literature report did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause could not be determined.The file has been opened from a literature report: intraocular lens exchange: indications, comparative outcomes by technique, and complications.Patients and methods: to determine the relative frequency of postoperative complications between techniques for all patients undergoing iol exchange from may 1, 2014 through august 31, 2020.The company lens was replaced with an company lens due to dislocation.The current study highlights lens dislocations and visual complaints as common indications for iol exchanges.While practice patterns have changed over time, explanations may include the inadequate support of the intraocular lens by the capsular bag or ciliary sulcus due to the operation or prior pathology, poor iol fixation, or zonular rupture.Another common reason for iol exchanges in the current study included subjective visual complaints following initial lens placement.The study concluded that 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: ANTERIOR CHAMBER PMMA SINGLEPIECE 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: 17070020
• MDR Text Key: 316582065
• Report Number: 1119421-2023-01039
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880087
• 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,Followup
• Report Date: 08/22/2023

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: MTA3U0
• Device Catalogue Number: MTA3U0.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2023
• 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: 55 YR