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

Model Number MA60AC

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A customer reported during the implant of an intraocular lens (iol), the patient's intraocular pressure (iop) caused the lens to move.The lens was removed during the initial procedure and replaced with a back up lens.Additional information was requested.

Manufacturer Narrative

Information was provided that a facility representative reported an intraocular lens (iol), with a description of, "other, intraocular pressure caused lens to move.Intervention: removed lens and replaced with anterior chamber." additional information was provided that in the surgeon's opinion, the lens did not cause or contribute to the event.The reported lens model was replaced with a different lens model.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
• MDR Report Key: 10385497
• MDR Text Key: 202220015
• Report Number: 1119421-2020-01114
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.150
• Device Lot Number: 12451796
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH II B CARTRIDGE; MONARCH II IOL DELIVERY SYS; MTA4U0; UNSPECIFIED 'ALCON' VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR