MAUDE Adverse Event Report: ALCON GRIESHABER AG FLEXIBLE IRIS RETRACTOR; CLIP, IRIS RETRACTOR

Catalog Number	611.74
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A healthcare professional reported that a small silicone stopper/slider from an ophthalmic iris retractor¿used to secure the iris hook¿was found to be missing during surgery.The surgeon was confident that the silicone component was not inside the patient¿s eye.An attempt was made to locate it under the lower eyelid (fornix area), but it was not visualized.The surgeon chose not to continue searching beneath the eyelids to avoid causing potential trauma.It was not visualized and within it could not be found.The patient will be reassessed at the postoperative appointment.Details regarding the procedure and the completion of the surgery are unknown.There was no patient harm.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Corrected information was provided in section b.2 and h.11.Upon further review, the initial decision to report was incorrect resulting in the initial report being submitted in error.This event small silicone stopper/slider from an ophthalmic iris retractor used to secure the iris hook was found to be missing during surgery is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.The previously submitted event under manufacturer mfg.Report num: 3003398873-2026-00059 does not meet the criteria for mdr reporting as per applicable regulations.Hence, no further reports will be submitted under mfg.Report num: 3003398873-2026-00059.The manufacturer internal reference number is: (b)(4).

• Brand Name: FLEXIBLE IRIS RETRACTOR
• Common Device Name: CLIP, IRIS RETRACTOR
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24604383
• Report Number: 3003398873-2026-00059
• Device Sequence Number: 10372467
• Product Code: HOC
• UDI-Device Identifier: 07612717012226
• UDI-Public: (01)07612717012226(17)280430(11)250516(10)17EFT6
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 Catalogue Number: 611.74
• Device Lot Number: 17EFT6
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 05/16/2025
• 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