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

Model Number	VTICM5_13.2 (-9.00/ 3.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search- one similar complaint event(s) within associated lots were found.H6- health effect- clinical code: 4581- 'dislocation/ subluxation' and 'iris cyst' h11- manufacturer narrative: decentration/ subluxation 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 following an implantable collamer lens (icl) implantation procedure, the patient experienced dislocation/ subluxation and an iris cyst post op.Reportedly 'the removement of the cyst is coming'.The lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected information: b5 - upon further review, this claim is deemed reportable.Supplemental #1 is no longer applicable.(b)(4).
Additional Manufacturer Narrative
Additional information: b5.- originally the claim was determined to be reportable, but upon further review, disregard initial mfr report as it is n/a.Claim# (b)(4).

• Brand Name: EVO/EVO + VISIAN 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 24464019
• Report Number: 2023826-2026-00344
• Device Sequence Number: 13166956
• Product Code: QCB
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/26/2026

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: VTICM5_13.2 (-9.00/ 3.0)
• Device Catalogue Number: VTICM5_13.2
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 03/19/2026; 09/04/2026; 09/10/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/09/2026; 03/19/2026; 09/09/2026; 09/10/2026
• Date Device Manufactured: 04/24/2024
• 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# UNK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Female