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

Model Number	VTICM5_13.2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Corneal Edema (1791); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 13.2mm vticm5_13.2 implantable collamer lens, -10.00/+2.0/090 (sphere/cylinder/axis), within the same surgery due to the lens was implanted upside down in the patients left eye (os).The lens was discarded.The lens was replaced with another same model/length lens and the problem was resolved.Post-op, corneal edema was resolving.See mfr.Report # 2023826-2023-02573 for replacement lens.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk; a5: unk; a6: unk; h6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- health effect- clinical code: "1791" should be added.B5- the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -10.00/2.0/090 (sphere/cylinder/axis) into the patient's left eye (os) upside down on (b)(6) 2023.Reportedly "the lens flipped inside the eye".The lens was implanted, removed, and replaced intraoperatively with a lens of the same parameters and the problem was resolved.Status of the eye: "cornea edema still resolving".The cause of the event is user error and its unknown if the device failed to perform as intended.Cause details provided: " icl loaded like normal rotated during unfolding and was upside down.Icl explanted and replaced." 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
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17253006
• Report Number: 2023826-2023-02572
• Device Sequence Number: 14776551
• Product Code: QCB
• UDI-Device Identifier: 00841542116596
• UDI-Public: 00841542116596
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/07/2023

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: 03/31/2024
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 08/20/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2022
• 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
• Patient Age: 22 YR
• Patient Sex: Male