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

Model Number	VICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a replacement 13.2mm vticm513.2 implantable collamer lens of -9.0 diopter tore during/broke during injection/delivery into the patient's right eye (od).
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 13.2mm vicm513.2 implantable collamer lens of -9.0 diopter into the patient's right eye (od) on (b)(6) 2024.The lens tore during injection/delivery into the eye.Intraoperatively the lens was removed.A replacement lens implant has been cancelled.Claim#: (b)(4).
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5: the lens was intraoperatively implanted and removed on (b)(6) 2024.Scheduled secondary procedure has been cancelled.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 ; 8002927902
• MDR Report Key: 18909474
• Report Number: 2023826-2024-01153
• Device Sequence Number: 20589864
• Product Code: QCB
• UDI-Device Identifier: 00840311300914
• UDI-Public: 00840311300914
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 02/29/2024

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: 09/30/2026
• Device Model Number: VICM5_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: Not provided
• Supplement Date Received by Manufacturer: 03/14/2024; 04/07/2024; 04/07/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/19/2024; 04/07/2024; 04/07/2024
• Date Device Manufactured: 10/17/2023
• 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# 1662667; FOAM TIP PLUNGER - LOT# 1660128
• Patient Age: 39 YR
• Patient Sex: Female