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

Model Number	VTICMO 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	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticmo 13.2 implantable collamer lens of diopter -17.0/2.5/107 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2024.The patient experienced excessive vaulting.Intraoperatively the lens was removed and replaced with a same model/length lens.Reportedly, "this lens is implanted into the eye at a 90 degree angle." the problem was resolved.The cause of the event was reported as unknown.
Additional Manufacturer Narrative
A4: a6: unk.H6: type of investigation: 4110: lens work order search: no similar complaint type events reported for units within the same lot.Claim #: 734043.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.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: 18744618
• Report Number: 2023826-2024-00779
• Device Sequence Number: 6380843
• Product Code: QCB
• UDI-Device Identifier: 00840311327843
• UDI-Public: 00840311327843
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/18/2024

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: 02/28/2026
• Device Model Number: VTICMO 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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
• Patient Age: 21 YR
• Patient Sex: Female