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

Model Number SN6AT9

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens implant surgery, the surgeon was implanting a lens and noticed a small tear.The surgeon tried to implant a second lens and the lens fell apart after implanting it in the eye.The surgeon removed it during the initial surgery.This record is for the second lens that fell apart.Additional information has been requested.

Manufacturer Narrative

Additional information provided in h.3., and h.10.The product was not returned for analysis.Photo evaluation: the returned picture appears to show an implanted iol.The iol appears to be damaged/broken into several pieces.Additional information: the complainant states the use of company viscoelastic which is not qualified to be used with the associated iol/company/cartridge combination.Based on our observation of the attached photo, the lens appears to be implanted in the eye and appears to be damaged/broken into several pieces.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).

Manufacturer Narrative

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: 9843762
• MDR Text Key: 186389702
• Report Number: 9612169-2020-00099
• 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,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: SN6AT9
• Device Catalogue Number: SN6AT9.200
• Device Lot Number: 21172406
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGE; MONARCH III HANDPIECE
• Patient Age: 70 YR