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

Model Number MA50BM

Device Problem Break (1069)

Patient Problems Capsular Contracture (1761); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the iol product history records were reviewed and documentation indicates the product met release criteria.Cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported after implanting an intraocular lens (iol), the haptic broke.The lens was removed during the initial procedure, however, the broken haptic had 'hurt' the patient's capsule resulting in the patient experiencing a capsular rupture.Additional information was requested.

Manufacturer Narrative

The lens was returned for evaluation.Solution and blood are dried on the lens.One haptic is broken in the distal area (not returned).The other haptic is missing due to optic damage at the haptic insertion area.The optic has been cut in half which is consistent with insertion and removal.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a non-qualified company ii (b) cartridge and company ii handpiece.The lens model is only qualified for use in the monarch (a) cartridges.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.The root cause is most likely related a failure to follow the dfu.The account used an unqualified lens/cartridge combination.The use of non-qualified combinations may result in delivery issues and/or damage.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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: 9072161
• MDR Text Key: 161245126
• Report Number: 1119421-2019-01504
• 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: 11/20/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.160
• Device Lot Number: 12613945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 11/06/2019
• Supplement Dates FDA Received: 10/23/2019; 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC; MA50BM, SN (B)(4); MONARCH II B CARTRIDGES; MONARCH II DELIVERY SYSTEM; MONARCH II IOL DELIVERY SYSTEM; MONARCH IIB CARTRIDGE; UNSPECIFIED DUOVISC
• Patient Outcome(s): Other
• Patient Age: 75 YR