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

Model Number	VTICMO13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: unk.A3: unk.A4: unk.A5: unk.A6: unk.B3: unk.D4: expiration date unk.D6a: unk.D6b: unk.H4: unk.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted an icl implantable collamer lens into the patients eye.The lens had rotated and remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: b5: lens repositioning was performed on (b)(6) 2023.Claim#: (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 13.2mm vticmo13.2; -15.00/2.0/110 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6)2023.The doctor reported the patient experienced lens rotation.The surgeon repositioned the lens and the problem was resolved.The cause of the event was reported as a patient related factor and unknown and noted, "worst squeezer i've ever done".H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.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 ; 6263037902
• MDR Report Key: 18360945
• Report Number: 2023826-2023-05554
• Device Sequence Number: 8182622
• Product Code: QCB
• UDI-Device Identifier: 00841542120944
• UDI-Public: 00841542120944
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: VTICMO13.2
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 01/24/2024; 02/21/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/29/2024; 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• 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-LIOLI-24, LOT#-UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male