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

Model Number	VTICMO13.2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -14.50/+1.5/151 (sphere/cylinder/axis).The lens flipped inside the eye, the surgeon attempted to reposition the lens but was unsuccessful.The lens was removed and the backup lens was implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Corrected data: b5-the reporter indicated the surgeon implanted a 13.2 vticmo 13.2 implantable collamer lens of diopter -14.5/+1.5/151 (sphere/cylinder/axis) into the patients left eye (os), reportedly, the "lens flipped inside the eye, surgeon tried reposition the lens, however he couldn't so the backup lens was used".The lens was repositioned.The lens was explanted and a back up lens of the same model, length was implanted.Reportedly, "i have had no news that there are any issues otherwise with the patient/implanted lenses, i would say that no news is good news!".H6-health effect- impact code: "4629" should be removed and code "4627" should be added.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: 17672691
• Report Number: 2023826-2023-03835
• Device Sequence Number: 6032693
• Product Code: QCB
• UDI-Device Identifier: 00840311327072
• UDI-Public: 00840311327072
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown