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

Model Number	MA60MA
Medical Device Problem Codes	Defective Device (2588); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported with a description of intraocular lens (iol) with increased surface reflex.The surgeon also stated his opinion that, the iol really looks a bit bent backwards, at least in the wide pupil at the slit lamp.In the pentacam it also looked partly like that.There was a patient contact but no patient impact was reported.The iol remains implanted.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in h.6., and h.10.No determination could be made from the provided photos.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and stated that, the lens material appears compressed.As per the surgeons opinion, it might be due to turbidity reaction.The patient had visual impairment.The patient was not hospitalized for the event.The event did not cased any unplanned drug, medical or surgical treatment.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• 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: 15631135
• Report Number: 1119421-2022-02214
• Device Sequence Number: 14942562
• Product Code: HQL
• UDI-Device Identifier: 00380650699329
• UDI-Public: 00380650699329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MAN040
• Device Lot Number: 10767622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 11/30/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/28/2022; 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2007
• 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: MONARCH IOL CARTRIDGE
• Patient Age: 55 YR
• Patient Sex: Female