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

Model Number	VICM5 13.2(-10.0)
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)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: work order search: no additional similar complaint type events within associated lots were found.Lens tear (noted during/after loading, delivery, implantation) - there was no damage reported to have been noticed during the inspection required by the dfu prior to use and preparation, which suggests a product deficiency did not contribute to the reported difficulties.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).
Event or Problem Description
The reporter indicated that during an implantable collamer lens (icl) implantation procedure, the lens tore /broke during injection/delivery into the eye.On a separate day due to the lens tear/break during injection/delivery into the eye, the lens was explanted.The problem was resolved.Cause of the event is unknown.
Additional Manufacturer Narrative
E1 - name and address: usa corrected to canada in initial mdr.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that during an implantable collamer lens (icl) implantation procedure, the lens tore/broke during injection/delivery into the eye.On a separate day due to the lens tear/break during injection/delivery into the eye, the lens was explanted.Additional information provided "torn haptic caused hemorrhage.Icl explanted".The problem was resolved.Cause of the event is unknown.D4 - serial #: (b)(6) corrected to (b)(6).G4 - premarket identification pma/510(k): p030016 combination product correct to no in initial cl.H6 - 4581: hyphema.Claim #: (b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS (ICL)
• 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 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22576999
• Report Number: 2023826-2025-01037
• Device Sequence Number: 9681539
• Product Code: MTA
• UDI-Device Identifier: 00840311300938
• UDI-Public: (01)00840311300938(11)241221(17)271130
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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
• Device Model Number: VICM5 13.2(-10.0)
• Device Catalogue Number: VICM5 13.2
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 11/05/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/28/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2024
• 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-UNK, LOT#-UNK.; INJECTOR MODEL-UNK, LOT#-UNK.; UNK-MODEL-UNK, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female