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

Model Number	VTICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -7.00/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patients right eye (od) on an unknown date.Excessive vault was reported.Lens remains implanted.No patient injury reported.Cause was reported as unknown.Additional information was requested but has not been provided to date.
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -7.00/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patients right eye (od) on (b)(6)2023.Excessive vault was reported.On (b)(6) 2024 the lens was exchanged for a smaller lens.This resolved the problem.No patient injury reported.Cause was reported as unknown.Additional information was requested but has not been provided to date.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -7.00/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patients right eye (od) on (b)(6)2023.Excessive vault was reported.On (b)(6) 2024 the lens was exchanged for a smaller lens.This resolved the problem.No patient injury reported.Cause was reported as unknown.Additional information was requested but has not been provided to date.

• Brand Name: IMPLANTABLE COLLAMER DEVICE (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
• MDR Report Key: 19661340
• Report Number: 2023826-2024-02825
• Device Sequence Number: 6624116
• Product Code: QCB
• UDI-Device Identifier: 00840311311965
• UDI-Public: 00840311311965
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/30/2024

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
• Device Expiration Date: 06/30/2026
• Device Model Number: VTICM5 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/30/2024
• Date Device Manufactured: 07/20/2023
• 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# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown