MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

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.Results from the product history record review indicated the product met release criteria.There has been one other complaint reported in the lot number.(b)(4).

Event Description

A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced an unexpected postoperative outcome of -6.00 diopters.The iol was exchanged for another lens with half a diopter less power three weeks following the initial implant procedure.

Manufacturer Narrative

Product evaluation: the returned lens is a monofocal single-piece lens.The lens was returned cut into two pieces inside a specimen cup.The specimen cup has been labeled with patient and surgeon information.No product labeling was returned with the sample.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is not in the diopter range; the value falls into the range of 7.5 or 8 diopters higher than what was reported.Product history records were reviewed and documentation indicated the product met release criteria.The most likely root cause was determined to be an inadequate line clearance conducted at cosmetics or lens casing.Based on the analysis of the complaint sample and process review, the scope of the investigation was limited.Nine potential lots were identified.The associated phrs were reviewed and confirmed to have adequate lot reconciliation documentation.This would indicate the lens exchange most likely occurred with a rejected lens due to an inadequate line clearance.Additional information provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Action taken: a voluntary medical device removal was initiated on (b)(6) 2020.All the non-implanted units from this lot (12726594) were recalled from the market.The fda was notified of this voluntary medical device removal (b)(6) 2020.Two corrective and preventive actions (capas) were identified to address inadequate line clearance and the contributing factor of rejected units left in an optical metrology fixture bin.There are no new complaints for the implanted lenses from this lot, and all non-implanted lenses from this lot has been recovered.Additional information provided in h.7., h.9.And h.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 9514351
• MDR Text Key: 172568954
• Report Number: 1119421-2019-02196
• Device Sequence Number: 1
• Product Code: KYB
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: AU00T0
• Device Lot Number: 12726594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 02/27/2020; 06/23/2020
• Supplement Dates FDA Received: 03/24/2020; 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC VISCOELASTIC.; UNSPECIFIED DUOVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR