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

Model Number MA60AC

Device Problems Failure to Align (2522); Material Deformation (2976)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

A customer reported an intraocular lens (iol) was difficult to load into the cartridge because the lens was very inflexible.The haptic of the lens also was crooked and it could not 'get right' anymore.Additional information was requested.

Manufacturer Narrative

The product was returned.Solution is dried on the lens.Both haptics are bent in the distal area.The optic is torn/split/cracked against a post of the lens case.A fold inspection could not be conducted due to the extensive lens damage.Product history records were reviewed and the documentation indicated the product met release criteria.An unspecified cartridge was indicated.It is unknown if qualified products were used.The model is only qualified for use in the (a) and (b) cartridges.The product investigation could not identify a root cause.A fold inspection could not be conducted due to the extensive lens damage.Haptic and optic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met approved release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of an unspecified cartridge.It is unknown if qualified products were used.The lens model is only qualified for use in approved cartridges.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8535802
• MDR Text Key: 142881519
• Report Number: 1119421-2019-00507
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2019

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: 06/30/2020
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.210
• Device Lot Number: 12386323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 06/28/2019; 09/09/2019
• Supplement Dates FDA Received: 07/11/2019; 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1