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

Model Number	MA60MA
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution and blood are dried on the lens.One haptic is bent in the gusset area and folded over and adhered to the optic by solution and blood.The opposite haptic is bent in several areas and broken in the distal area.The optic is cut in half, typical of insertion and removal from the eye.The optic is broken and crushed over a post in the lens case.All product and batch history records are quality reviewed prior to product release.The file indicates the use of a non-qualified cartridge, handpiece and viscoelastic.Broken haptic damage was observed.The root cause is most likely related a failure to follow the ifu (instructions for use).The account used an unqualified lens/company delivery system combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during implantation of intraocular lens (iol) procedure, it was found that haptic would not unfold in the patients eye.The surgeon had removed the iol during initial procedure.Additional information received and stated that, the incision was enlarged and suture was used during the procedure.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14039743
• Report Number: 1119421-2022-00692
• Device Sequence Number: 6301276
• Product Code: HQL
• UDI-Device Identifier: 00380650699312
• UDI-Public: 00380650699312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2026
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MAN030
• Device Lot Number: 15200180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMIVISIC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male