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

Model Number AU00T0

Device Problem Defective Device (2588)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

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 facility representative reported that during a cataract surgery with an intraocular lens (iol) implantation, the nozzle was found to be "defective." the iol was implanted with no reported harm to the patient.Additional information has been requested.

Manufacturer Narrative

The device was returned loose in a bag.The lens was not returned in the device.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.The end of the tip is bent backwards.Product history records were reviewed and documentation, indicated the product met release criteria.There were no issues found related to the product lot, nozzle lot, company nozzle control number or the vendor nozzle control number.A qualified viscoelastic was indicated.The root cause for the damage observed, to the returned used device tip cannot be determined.All nozzles receive a 100% inspection for cosmetic issues and damage.All company assembled devices receive an additional 100% inspection for cosmetic issues and damage.The damage observed, the returned device tip would not have met company's release criteria for this product.Procedures and processes exist within the manufacturing environment that focus on protection of the nozzle tip.Nozzles are a molded product.The manufacturing process is a validated operation, with specifications that are maintained and documented.If the tip is inadvertently pressed against a hard surface, the tip could be damaged in this manner.Due to the used nature of the device, it cannot be verified, that the damage was present when opened.A director of global quality customer affairs (gqca) has discussed, the case with the reporter.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: 11435497
• MDR Text Key: 238400216
• Report Number: 1119421-2021-00500
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394772
• UDI-Public: 00380652394772
• 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
• Report Date: 04/21/2021

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: 11/05/2023
• Device Model Number: AU00T0
• Device Lot Number: 15110354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE