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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's eye.It has been reported the lens has rotated.Lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5 - the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -6.50/+2.5/171 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2022.The patient experienced lens rotation and blurred vision.On (b)(6) 2022 the lens was exchanged with a longer length lens.This resolved the problem.The cause of the event was reported as the device and noted "short diameter".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 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15341923
• Report Number: 2023826-2022-03007
• Device Sequence Number: 17275375
• Product Code: MTA
• UDI-Device Identifier: 00841542114509
• UDI-Public: 00841542114509
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: VTICM5_12.6
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male