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

Model Number SN60WF

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the iol was clamped by plunger.At the time when the part of the lens was in the front chamber and it was impossible to remove it together with the cartridge, the damaged lens was implanted.As a result, cracks were visualized in the optical part.The iol was explanted and replaced with a new one.The patient did not have any complications during the continuation of the operation and the postoperative period.

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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Photos (3) provided appears to show the same iol from different angles.The iol is in the lens case base outside of the lens case well area.The iol appears to be in a few segments and appears to be mangled.Photos (2) provided showing an unknown injector.Additional information: the complainant indicates -"there was used not-company injector." based on our observation of the attached photo, the iol is broken into a few segments and mangled.There is also a photo of a non-company injector.A definitive determination of damage for the reported complaint cannot be made without the evaluation of the physical products.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 directions for use (dfu), as the surgeon states the use of non-qualified combination.The use of non-qualified combinations may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 13059231
• MDR Text Key: 282609257
• Report Number: 9612169-2021-00301
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093269
• UDI-Public: 00380655093269
• Combination Product (y/n): N
• Reporter Country Code: BO
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.235
• Device Lot Number: 25159079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC OVD; MONARCH III CARTRIDGE D; UNSPECIFIED INJECTOR (NON ALCON)
• Patient Age: 51 YR
• Patient Sex: Female