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

Model Number	VICM5 12.6 (-4.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.H11 - manufacturer narrative: significant glare and/or halos is identified in the labeling as a known potential adverse event following icl implantation.Claim #(b)(4).
Event or Problem Description
A facility representative reported that an implantable collamer lens was implanted into the patient's eye.The surgeon notes there was a problem with insertion, lens got stuck and could not get unfurled.The lens was implanted upside down.It was noted there was patient injury, mild endothelial damage and glare/haloes with small ring in vision.Intraoperatively the lens was removed and replaced with a same length and power lens.The problem was resolved.The cause of the event was reported as the device and use error.

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 23612483
• Report Number: 2023826-2025-01848
• Device Sequence Number: 9821220
• Product Code: MTA
• UDI-Device Identifier: 00840311300495
• UDI-Public: (01)00840311300495(11)240511(17)270430
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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 Model Number: VICM5 12.6 (-4.5)
• Device Catalogue Number: VICM5 12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 05/11/2024
• 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: INJECTOR MODEL-LIOLI-24, LOT#- GACLA004
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female