MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).See claim (b)(4) for fellow eye.
Event or Problem Description
A facility representative reported that during an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault with significant reduction in iridocorneal angles.The lens was exchanged which resolved the problem.Cause of the event was reported as patient related factor.This is report 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Additional Manufacturer Narrative
E1: (b)(6).E2: yes.E3: physician.Claim (b)(4).See claim 434612 for fellow eye.
Additional Manufacturer Narrative
Corrected data: b5 - the lens was exchanged with a shorter length lens.The problem was resolved.Injector model-msi-pf; lot# unk - should be removed as it is n/a.Cartridge model-sfc-45; lot# unk - should be removed as it is n/a.Foam tip plunger model-ftp; lot# unk - should be removed as it is n/a.H6 - health effect clinical code: 4581 - significant reduction of irido-corneal angles, should have been noted in previous medwatch h11 section.Manufacturer narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene munize ; 1911 walker avenue; suite: 210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 21578288
• Report Number: 2023826-2025-00375
• Device Sequence Number: 20900875
• Product Code: QCB
• UDI-Device Identifier: 00841542114622
• UDI-Public: (01)00841542114622(11)220831(17)240731
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: VTICM5 12.6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 05/19/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/12/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: CARTRIDGE MODEL-SFC-45, LOT# UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT# UNK.; INJECTOR MODEL-MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female