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

Model Number SA60AT

Device Problem Material Deformation (2976)

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

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.Both haptics are bent in the gusset and distal area.The optic is torn/split/cracked in multiple places.We are unable to conduct a fold inspection due to the extensive optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause cannot be determined for the complaint.Further clarification was not provided for the complaint of "product failed the testing - iol was folded".It is unknown what steps/process was used for the reported ¿testing¿ of the lens prior to customer use.Each individual lens is subjected to multiple 100% inspections and tests during the manufacturing process prior to final quality release from the manufacturing facility in order to determine if the lens meets acceptability by set quality standards.The directions for use does not condone nor recommend additional testing activities prior to the use of the lens, as lens damage may occur due to mishandling.A fold test could not be conducted due to the damage of the returned lens.There have been no other complaints reported in the lot number.This product malfunction was originally reported under an alternative summary report.The sample has been returned and investigation was updated, which prompts evaluation and conclusion coding to be updated.As the alternative summary report has been revoked, the updated information (product investigation and coding) is being sent via this 3500a report.The manufacturer internal reference number is: (b)(4).

Event Description

A supplier reported an intraocular lens (iol) was folded and failed testing.Another lens was opened to complete the procedure.

• 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: 9312902
• MDR Text Key: 173726115
• Report Number: 1119421-2019-01894
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/12/2019

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: 02/28/2023
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.210
• Device Lot Number: 12602444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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