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

Model Number	VTICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per reporter, "icl has been implanted/explanted but it will not be replaced.The surgeon prefers to do a pkr (iris slightly affected during the explantation - va is same as the pre-op).Patient is ok, visual acuity is same as before the surgery, but as the iris slightly affected during the explantation." claim# (b)(4).
Additional Manufacturer Narrative
H6 - investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon intraoperatively implanted and removed a 13.2mm vticm5_13.2 -7.50/1.0/092 (sphere/cylinder/axis) implantable collamer lens from the patient's right eye (od) on (b)(6) 2024.Lens was implanted upside down.Reportedly, "new lens implantation is not scheduled for the moment." cause of event was not reported.
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
(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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr; suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19459601
• Report Number: 2023826-2024-02547
• Device Sequence Number: 7870733
• Product Code: QCB
• UDI-Device Identifier: 00840311311132
• UDI-Public: 00840311311132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 05/22/2024

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 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 08/22/2024; 09/17/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/05/2024; 08/22/2024; 10/15/2024
• Date Device Manufactured: 03/18/2024
• 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: FOAM TIP PLUNGER, LOT# 1660140; SFC-45, LOT# 1721561
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female