MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT5

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Failure of Implant (1924)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

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 healthcare professional reported what appeared to be a small tear at the haptic optic junction following an intraocular lens implantation procedure.The lens remains implanted and in the appropriate position.

Manufacturer Narrative

Additional information has been provided in d.10, h.3, h.6 and h.10.The product was not returned for analysis.A non-qualified viscoelastic was used.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the surgeon states the use of non-qualified viscoelastic.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 11141186
• MDR Text Key: 227070044
• Report Number: 9612169-2021-00006
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.215
• Device Lot Number: 21246503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON; MONARCH III IOL INJECTOR; MONARCH IOL CARTRIDGE D
• Patient Age: 89 YR