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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2, -12.0/1.0/080 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.Refractive surprise, blurred vision, and excessive vault was observed.Lens remians implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter-12.0/+1.0/80 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced an excessive vault and refractive surprise.The lens remains implanted and the problem was not resolved.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18075201
• Report Number: 2023826-2023-04920
• Device Sequence Number: 7665321
• Product Code: QCB
• UDI-Device Identifier: 00840311311224
• UDI-Public: 00840311311224
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 10/17/2023

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: 06/30/2026
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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: INJECTOR MODEL#MSI-PF,LOT#UNK
• Patient Age: 30 YR
• Patient Sex: Female