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

Model Number	MA60MA
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A purchaser reported that at the time of intraocular lens (iol) implantation, when the lens package was opened, it was already verified that the lens was damaged and strap was broken (broken haptic).Therefore, the surgery was not completed and the patient was left aphakic and another lens was implanted after three days.The surgery was a success.
Additional Manufacturer Narrative
The product was returned.One haptic is broken off with a piece of lens material and returned loose in the lens case.The optic is broken and crushed by two posts in the lens case.All product and batch history records are quality reviewed prior to product release.The lens was damaged.Due to the absence of clinical solution on the returned sample the root cause is potentially manufacturing related.If the lens becomes misaligned in the lens case lens damage may occur.Photos were available in the file.Two photos showed the carton (edge and posterior).Two photos displayed the lens in the same position.The lens was shown outside the well area of the lens case base, positioned posterior surface up.One haptic was broken from the optic.This haptic was also in the photo placed next to the lens.There appeared to be a portion of optic material at the gusset area of the broken haptic.The optic appeared crushed in the area where the broken haptic insertion area would have been located.Another area of the optic edge also appeared crushed.A light source glare was observed on the optic.It cannot be verified from the photos if viscoelastic was present on the lens.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: 17496384
• Report Number: 1119421-2023-01426
• Device Sequence Number: 16780151
• Product Code: HQL
• UDI-Device Identifier: 00380650699275
• UDI-Public: 00380650699275
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.040
• Device Lot Number: 12667365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG