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

Model Number	VTICM5_12.6 (-4.5/1.0)
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault, refractive change over time, lens opacity, and glare/halos.Reportedly, "this patient has a low vault od and rotation os' and [?]the weird thing that is now happening is his refraction is shifting more and more myopic," and "a nuclear sclerotic cataract growing (not visually significant in the sense that he still corrects to 20/15).He does experience glare." the lens remains implanted.
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Manufacturer narrative each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Claim#: (b)(4).
Additional Manufacturer Narrative
B5: the patient experienced refractive change over-time.The lens was later exchanged for a longer length lens and the problem was resolved.Cause of the event was other.Reportedly, "icl was too small; patient is in between icl sizes." and "low vault.Icl rotated.Patient had residual cylinder.Also had progressive myopia, possible nsc forming.Resolved with lens exchange for now.Cataract progression uncertain." claim# (b)(4).

• Brand Name: 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 23724582
• Report Number: 2023826-2025-01942
• Device Sequence Number: 21489999
• Product Code: QCB
• UDI-Device Identifier: 00840311307715
• UDI-Public: (01)00840311307715(11)241007(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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_12.6 (-4.5/1.0)
• Device Catalogue Number: VTICM5_12.6
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 10/07/2024
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown