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

Model Number SN60AT

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

This product malfunction was originally reported under an alternative summary report (e2000003).The sample has been returned and investigation was updated, which prompts evaluation and conclusion coding to be updated.As the alternative summary report e2000003 has been revoked, the updated information (product investigation and coding) is being sent via this 3500a report.The product was returned.One haptic distal tip area is nick/chipped.The haptic/optic junction area has a small nick/chip, which may have been interpreted as by the customer as the reported complaint of "crease".The damage appears to be caused by a post of the lens case.Product history records were reviewed and the documentation indicated the product met release criteria.The haptic/optic junction area has a small nick/chip, which may have been interpreted as by the customer as the reported complaint of "crease".The damage appears to be caused by a post of the lens case.Due to the absence of clinical solution on the returned sample the root cause is potentially manufacturing related.If the lens becomes misaligned in the lens case lens damage may occur.(b)(4).

Event Description

The surgeon found crease on the optic close to the haptic on an intraocular lens (iol).The surgeon used a backup lens to complete the procedure.There was no reported patient impact.Additional information was requested.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 9086852
• MDR Text Key: 165106223
• Report Number: 1119421-2019-01532
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.125
• Device Lot Number: 12427984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1