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

Model Number	VTICM5_12.1
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	03/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.1mm vticm5_12.1 implantable collamer lens of diopter -12.50/3.5/100 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2024.The patient experienced an elevated iop.On (b)(6) 2024 the lens was explanted.On the same day the lens was replaced with the same model, length lens and the problem was resolved.
Additional Manufacturer Narrative
H6: investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H6: medical device problem code: 1494- off-label use (acd<3.0mm).Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- medical device problem code (a): "1494" should be removed.(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: 19226833
• Report Number: 2023826-2024-02051
• Device Sequence Number: 6882460
• Product Code: QCB
• UDI-Device Identifier: 00840311305919
• UDI-Public: 00840311305919
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/30/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: VTICM5_12.1
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/17/2024
• Date Device Manufactured: 02/28/2024
• 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: CARTRIDGE MODEL: SFC-45: LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male