MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that following an intraocular lens (iol) implant procedure, the patient had "iol has a diffuse haze and he is noticing that the patient's vision is getting worse.This has been getting gradually hazier over the past 6-12 months." additional information has been requested.

Event Description

The surgeon reported the intraocular lens (iol) was replaced in a secondary procedure with another iol.The surgeon reported the patient is happy and doing fine one day postop.He also reported slight postop corneal edema with no reported treatment.

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Evaluation summary: the explanted lens was returned adhered in viscoelastic to the interior of a blue plastic tray.Viscoelastic and what appears to be dark dried blood was also observed on the lens.The lens was cleaned using lphse to remove viscoelastic and blood from the lens.The lens was allowed to air dry.The lens did not appear hazy after removal of viscoelastic and dried blood.There was no indication of glistening attribute present in the optic material when viewed using the microscope at varying degrees.The posterior surface of the optic has several lines of scratches.This may have been misinterpreted as the complaint of iol haze and glistenings.The optic material appeared clear except in the areas of optic damage.Associated product information was not provided.The root cause could not be determined for the reported issue of iol haze, blurred vision, explant, glistenings.It is unknown if a qualified combination of associated products were used with this lens.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 RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10779315
• MDR Text Key: 216316898
• Report Number: 1119421-2020-01604
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 12482636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/14/2020; 03/10/2021
• Supplement Dates FDA Received: 01/11/2021; 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR