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

Model Number SN6AT3

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.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 facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision at distance.The iol was replaced for another lens model with the same lens diopter approximately one month following the initial implant procedure.

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Additional information: the complainant states the use of a viscoelastic which is not qualified to be used with the associated iol/cartridge/handpiece combination.Root cause: the root cause for the reported complaint could not be determined.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: 9703294
• MDR Text Key: 179227302
• Report Number: 9612169-2020-00055
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.205
• Device Lot Number: 21144749
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTFT0.205, TFNT00 IN ULTRASERT; ORA W VERIFEYE PLUS SURG CART; UNSPECIFIED HANDPIECE, ITC; UNSPECIFIED PROVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR