MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, opaque iol noted after 10 years of implantation in eye.
Additional Manufacturer Narrative
The product was not returned for analysis.Provided first photograph presents a monofocal pciol visible through a dilated round pupil.Anterior iol surface opacities are apparent from approximately the 5:00 to 7:00 o¿clock extending from 1 -2 mm from the edge of the lens.The appearance of these opacites likely represents lens epithelial cell on-growth (lecog).Additionally, this lens appears to be clouded throughout the entire lens.Provided second photograph presents what appears to be an identical, or if not a very similar, photograph to the photo described above.The significant findings presented in this photograph represent the same as stated above.Provided thirds presents a monofocal posterior chamber intraocular lens (pciol) through a dilated pupil.The lens appears centered, the lens is clear without any posterior or anterior opacification.Based on observation of the attached photo, an opaque or cloud is observed on one iol and a clear iol in the other picture.Additionally, the eye with the cloudy lens appears to have lens epithelial cell on-growth (lecog).Root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17069783
• Report Number: 9612169-2023-00419
• Device Sequence Number: 12285780
• Product Code: HQL
• UDI-Device Identifier: 00380655093207
• UDI-Public: 00380655093207
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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: 01/31/2018
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.205
• Device Lot Number: 21075403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2013
• 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: DUOVISC; MONARCH III CARTRIDGE C; MONARCH III INJECTOR
• Patient Sex: Unknown