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

Model Number	VTICMO12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2001
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm, vticmo12.6, -14.5/3.0/086 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.Low vault with rotation was observed, the lens was repositioned on (b)(6) 2023, but did not resolve the problem.Lens remain implanted.Cause of the event is reported as other, device did not fail to perform as intended, small size lens with rotation and changing astigmatism.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
B5 - lens explanted.H3: device evaluation - lens was returned in microcentrifuge vial dry with residue/debris on product.Visual inspection found optic torn and haptic broken.Dimensional inspection found the lens to be within specification.(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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17163482
• Report Number: 2023826-2023-02300
• Device Sequence Number: 5421733
• Product Code: QCB
• UDI-Device Identifier: 00840311323838
• UDI-Public: 00840311323838
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 06/17/2025
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/24/2023; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-TF,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male