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

Model Number	SN60WF
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, white spots appeared on the lens.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6 and h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.First provided photo shows what appears to be an implanted intraocular lens (iol).There is a light reflection and white spots over the lens.Second and third provided photos show an implanted iol.There appear to be multiple white spots over the optic.The exact location of the spots (anterior or posterior surface) cannot be confirmed from the returned photo.The photographs demonstrate the following significant findings: there are three photos of the same eye with the second photo having the best image.The photo is of an iol through a dilated pupil.There are a few white spots in the photo either on or within the iol.The spots are small and one would assume they have no impact on the patient vision.These photos appear to be glistening.Glistening appears in the first few months after iol surgery.Glistenings are microvacuoles of fluid that form within an iol when it is exposed to an aqueous environment.They range in size between 1-20 microns.In studies that evaluated glistening, the frequency of glistenings was related to time post surgery, dioptric power, postoperative inflammation, and phacotrabeculectomy.Based on our observation of the attached photo, the reported white spots appear to be glistening.Glistening appears in the first few months after iol surgery.Glistenings are microvacuoles of fluid that form within an iol when it is exposed to an aqueous environment.They range in size between 1-20 microns.In studies that evaluated glistening, the frequency of glistenings was related to time post surgery, dioptric power, postoperative inflammation, and phacotrabeculectomy.The root cause for the reported complaint could not be determined.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: 23767958
• Report Number: 9612169-2025-02471
• Device Sequence Number: 10562720
• Product Code: HQL
• UDI-Device Identifier: 00380655093139
• UDI-Public: (01)00380655093139(17)251031(11)201113(10)21289305
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 10/31/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.170
• Device Lot Number: 21289305
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/06/2026
• Date Device Manufactured: 11/13/2020
• 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
• Patient Sex: Unknown