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

Model Number	VTICM5_12,6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -08.50/+1.5/072 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2023.An lri was performed to correct residual astigmatism on (b)(6) 2023.The patients latest exam on (b)(6) 2023 indicated va sc 20/40-2.The surgeon plans to rotate (reposition) the lens.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6: health impact - additional surgery: 4625 - lri surgery.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
B5: the lens was repositioned on (b)(6) 2023 and the problem was resolved.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: 17515429
• Report Number: 2023826-2023-03417
• Device Sequence Number: 5607885
• Product Code: QCB
• UDI-Device Identifier: 00841542114769
• UDI-Public: 00841542114769
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 04/30/2024
• Device Model Number: VTICM5_12,6
• 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: 08/25/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2022
• 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 Sex: Female