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	Conjunctivitis (1784); Posterior Capsule Opacification (4807)
Date of Event	03/06/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implantation procedure, a posteriorly dislocated lens was observed, with an open fundus in the affected eye, and surgical repair of the eye was planned.Surgery was recommended.Under local anesthesia, the eye was prepared and draped following periocular cleaning.The eyelids were opened using an eye speculum, and side-port openings were created with an mvr (micro vitreoretinal blade) instrument.A 2.8 mm main incision was made, through which the dislocated lens was removed.An anterior vitrectomy was then performed, and a three-piece intraocular lens was implanted in the sulcus.The main incision was secured with a single suture.Following a subconjunctival antibiotic injection, a leak test was performed, and the procedure was completed successfully.The diagnosis included blepharoconjunctivitis and post-surgical cataract.Additional information was requested and received, stating that the lens was removed from the patient's eye, discarded during the surgery, and thrown away.The patient's condition was very poor.The surgeon informed the patient that nothing more could be done for that eye and that the patient had suffered a 40% loss of vision.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 ; +1(800)757-9780
• MDR Report Key: 50814632
• Report Number: 9612169-2026-02107
• Device Sequence Number: 10697014
• Product Code: HQL
• UDI-Device Identifier: 00380655093153
• UDI-Public: (01)00380655093153(17)151231(11)110107(10)21025307
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 12/31/2015
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.180
• Device Lot Number: 21025307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 01/07/2011
• 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 Sex: Male