MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS; PHAKIC INTRAOCULAR LENS

Model Number	VICM5_12.1 (-10.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	03/21/1981
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
4110: a lens work order search has been performed: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
A facility representative reported that an implantable collamer lens (icl) lens tore/broke during injection/delivery into the eye.Elevated iop was observed.Medication was provided.The lens was intraoperatively implanted, removed, and replaced.The problem was resolved.Cause of the event was the device.

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 24339927
• Report Number: 2023826-2026-00206
• Device Sequence Number: 11965132
• Product Code: MTA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: VICM5_12.1 (-10.0)
• Device Catalogue Number: VICM5_12.1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 06/02/2025
• 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# 1833211.; FOAM TIP PLUNGER - LOT# 1811018.; INJECTOR MODEL: MSI-PF - LOT# 1859863.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female