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

Model Number	VTICM5_13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -9.0/+2.0/72 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on - (b)(6) 2023.The patient experienced lens rotation and refractive surprise.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Device manufacture date: "31-july-2026" should be removed and "20-aug-2023" should be added.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -9.0/+2.0/72 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023 the patient experienced a refractive surprise and lens rotation not associated with low vault.The lens remains implanted and the problem has been resolved.Additional information provided: "no surgical intervention will be planned.The patient will be monitored and will correct his residual refraction with glasses." the cause of the event is unknown.(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 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18672852
• Report Number: 2023826-2024-00614
• Device Sequence Number: 20660243
• Product Code: QCB
• UDI-Device Identifier: 00840311311729
• UDI-Public: 00840311311729
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2024

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: 07/31/2026
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 04/28/2024; 06/11/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/28/2024; 06/11/2024
• Date Device Manufactured: 08/20/2023
• 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 MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Age: 35 YR
• Patient Sex: Male