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

Model Number SN60WF

Device Problem Fracture (1260)

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

A chemist reported that during an intraocular lens (iol) implant procedure, during injection of the lens, a fracture in the optic is evident.The iol was removed and replaced with same model lens during the initial procedure on the same day.Additional information was requested.

Manufacturer Narrative

A sample device was not returned for analysis.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

The product was returned for analysis and the reported damage was observed.Iol returned pressed down between two (2) posts of the iol case base resulting in iol damage.Solution is dried on both surfaces of the optic and one haptic.One haptic is broken/torn and not returned, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable with loose fibers & particulate.The associated qualified cartridge was returned and evaluated.Viscoelastic was observed dried in the cartridge.Heavy stress lines were observed beginning just past the parting line.The stress lines have enlarged into a long, wide aneurysm along the posterior surface of the tip.The cartridge also displayed evidence of being placed into a handpiece.One locking tab was fully smashed.The other locking tab was only partly compressed.This drastic uneven compression would suggest that the cartridge may not have been correctly seated into the handpiece prior to the delivery attempt.The reported optic damage was observed.The used lens and associated cartridge were returned and evaluated.Based on the lens evaluation and the used associated cartridge, the root cause of the observed optic damage may be related to a failure to follow the instructions for use (ifu).There is uneven compression evidence which would suggest that the cartridge may not have been fully seated in the handpiece.This could have caused the lens to deploy incorrectly or the plunger to be misaligned during advancement, which could result in product damage.Per the ifu, insert the cartridge into the handpiece and slide the cartridge fully forward into the handpiece slot until it is secured firmly into position.Advance the plunger in one slow motion to advance and fold the optic.The plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The cartridge also displayed heavy stress and a long, wide posterior aneurysm.This type of damage may occur if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge, it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.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: 13720758
• MDR Text Key: 287019658
• Report Number: 9612169-2022-00106
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093191
• UDI-Public: 00380655093191
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• 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.200
• Device Lot Number: 21290523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL, CARTRIDGE D