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

Model Number	SN60WF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Vitreous Detachment (2445); Diplopia/Double Vision (4802)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A non-health care professional reported with a description, the intra ocular lens (iol) implanted in 2007 in the left eye had slipped out of its position.A stabilization ring was implanted in the strabismus treatment.Iol dislocated for approximately 8 years and since then double vision fluctuated in intensity.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in a.2.,b.3.,b.5.,b.6.,b.7.,d.6a.,d.10 and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, after the surgery patient became nearsighted.The company stabilization ring was also implanted with the company intra ocular lens (iol) in the same surgery.The iol dislocation occurred around (b)(6) 2015 and the patient underwent iol repositioning on (b)(6) 2023.The patient experienced flashes, distorted faces, black spots, posterior vitreous detachment, dry eye syndrome, hyperopia, astigmatism and presbyopia.Additional information was received and stated, according to healthcare professional records, the patient in question received a company lens in 2007 in left eye together with a capsular tension ring presumably due to an unstable zonule.
Event or Problem Description
Additional information was received and stated, after the surgery patient became nearsighted.The company stabilization ring was also implanted with the company intra ocular lens (iol) in the same surgery.The iol dislocation occurred around 2015/16 and the patient underwent iol repositioning on (b)(6) 2023.The patient experienced dry eye syndrome, hyperopia, astigmatism and presbyopia.
Additional Manufacturer Narrative
Correction information was provided in b.5., b.7., d.4., h.6 and h.11.Correction: fda patient codes e081906 and e0838 was removed.Correction: eval method code b22 was replaced with b14.The product was not returned for analysis.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).
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received, patient stated that the ophthalmology department at the hospital would like to know whether the lens can still be folded back after years for the purpose of removing the lens and implantation of a new one.

• 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: 22307259
• Report Number: 9612169-2025-01275
• Device Sequence Number: 7934663
• Product Code: HQL
• UDI-Device Identifier: 00380655093214
• UDI-Public: (01)00380655093214(17)120229(11)070420(10)20701955
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2012
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.210
• Device Lot Number: 20701955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 08/21/2025; 03/23/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/15/2025; 09/11/2025; 04/13/2026
• Date Device Manufactured: 04/20/2007
• 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: CEFUROXIME.; KOCHER SPATULA.; MYCOPHENOLATE.; REFORM CAPSULAR TENSION RING.; UNSPECIFIED STABILIZATION RING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female