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

Model Number	VTICMO12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots.Claim# (b)(4).
Event or Problem Description
The reporter indicated that on a 12.6mm vticmo12.6 implantable collamer lens of a -16.5/2.5/086 (sphere/cylinder/axis) was implanted into the patient's left eye (os).Reportedly, "there was a lint-like substance on sfc-45." there was no problem with the eye.
Additional Manufacturer Narrative
H3: device evaluation - cartridge returned in device tray.Visible inspection found no visible damage to device and no lint was noted on the cartridge.Cartridge was inspected under different lighting and magnification.Cartridge case was opened and cartridge was loose in case.H6: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device; have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim# (b)(4).
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
Aware date: 12/21/2023 claim# (b)(4).
Additional Manufacturer Narrative
Initial mdr is not reportable.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 ; 800 royal oaks dr. suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18421045
• Report Number: 2023826-2023-05811
• Device Sequence Number: 20537593
• Product Code: QCB
• UDI-Device Identifier: 00840311323517
• UDI-Public: 00840311323517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: VTICMO12.6
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 04/10/2024; 07/05/2024; 12/23/2024; 01/08/2026
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 04/15/2024; 08/04/2024; 12/24/2024; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2023
• 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# 1585256.; FOAM TIP PLUNGER - LOT# UNK.; INJECTOR MODEL: MSI-PF - LOT# UNK.
• Patient Age: 27 YR
• Patient Sex: Male