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

Model Number	VICM5_12.6 (-13.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that during an implantable collamer lens (icl) implantation procedure, the lens was implanted upside down.The patient experienced poor naked eye vision.The lens was later exchanged for a replacement lens and the problem was resolved.The cause of the event was a user error.Reportedly, "neglected to check after inserting the lens.
Additional Manufacturer Narrative
Manufacturer narrative: secondary surgical intervention to remove and replace the lens are identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Additional Manufacturer Narrative
Correction: d4: g1; claim# (b)(4).

• 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 ave; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 22308949
• Report Number: 2023826-2025-00883
• Device Sequence Number: 12761735
• Product Code: MTA
• UDI-Device Identifier: 00840311300679
• UDI-Public: (01)00840311300679(11)240929(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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 (-13.5)
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 09/29/2024
• 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: CARTRIDGE MODEL: SFC-45 - LOT# UNK; FOAM TIP PLUNGER - LOT #UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male