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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2022

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.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

An inventory management specialist reported that during an intraocular lens (iol) implant procedure, a torn lens was noted with patient contact.Additional information was received stating there was no patient harm and surgery completed on same day.

Manufacturer Narrative

The product was returned for analysis and the reported complaint was observed.Iol returned in two pieces (cut in half) in the lens case.Solution and blood are dried on both surfaces of the optic and haptics.One haptic is intact, the other haptic is folded and adhered to the optic with solution.The optic is cut in two and scratched/marked-rejectable.The complainant indicates the use of viscoelastic, which is not qualified for use with associated cartridge.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14787705
• MDR Text Key: 295801093
• Report Number: 9612169-2022-00293
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652250856
• UDI-Public: 00380652250856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.130
• Device Lot Number: 21204239
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/14/2022
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III CARTRIDGE D; PROVISC; UNSPECIFIED INJECTOR