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

Model Number SN60WF

Device Problem Material Opacification (1426)

Patient Problem Blurred Vision (2137)

Event Date 09/25/2023

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

Event Description

A physician reported that a company lens was implanted in the patient's right eye in the month of january & patient come back with a complaint of blurry vision and lens opacity.Physician advised the patient to have the lens removed.He removed the lens and implanted an another company lens in the patient's right eye.Physician shared concerns related to the opacity of lens & handed over the explanted iol.Additional information was received stating that before lens explant, the patient had yag capsulotomy.

Manufacturer Narrative

The product was returned for analysis, numerous scratches were observed on the returned iol and this damage was not mentioned by the customer.Iol returned in a glass vial with unknown solution.One haptic is broken/torn and not returned, the other haptic has slight scratches.The optic is torn/split-cut with numerous scratch/marks across the surface.Opacification seen in the supplied videos and photos was not observed on the returned sample.The returned video shows an iol held with tweezers/forceps, one haptic is missing.The reported complaint cannot be verified from the returned video.The returned photos show an implanted iol on a monitor screen, there appears to be white/yellow marks on the optic but the exact location of the marks cannot be confirmed.We are unable to determine the root cause for the reported complaint.The iol was returned in an unknown solution, the opacification seen in the supplied videos and photos was not observed on the returned sample.The product was also subject to handling as the reported iol was explanted and returned in an unknown solution.Numerous scratches were observed on the returned iol and this damage was not mentioned by the customer.All iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.We are unable to determine the root cause for the reported complaint.The iol was returned in an unknown solution, the opacification seen in the supplied videos and photos was not observed on the returned sample.The product was also subject to handling as the reported iol was explanted and returned in an unknown solution.Numerous scratches were observed on the returned iol and this damage was not mentioned by the customer.All iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.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: 17976716
• MDR Text Key: 326167782
• Report Number: 9612169-2023-00738
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093191
• UDI-Public: 00380655093191
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.200
• Device Lot Number: 21166193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female