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

Model Number	VTICM5_13.2
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
Additional Manufacturer Narrative
Lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -7.50/4.0/084 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2022.The surgeon reports lens rotation with a planned replacement.Lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -7.50/4.0/084 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2022.Repositioning was attempted on (b)(6) 2022 and did not resolve the problem.On (b)(6)2023 the lens was explanted.In a separate surgery later that day a longer length lens of the same power was implanted.Additional information states the patient rubbed eye on (b)(6) 2023 causing a wound leak.The surgeon attempted to suture the wound and sent the patient to a different doctor for possible glue to close the incision; seidel and hypotony.Cause of the event was reported as unknown.The problem was not resolved.A lens work order search was performed and no similar complaint types were found in the same lens lot.D9: returned to manufacturer 05/01/2023.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found the optic torn.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16273842
• Report Number: 2023826-2023-00369
• Device Sequence Number: 14939713
• Product Code: QCB
• UDI-Device Identifier: 00841542116282
• UDI-Public: 00841542116282
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2022

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 Expiration Date: 05/31/2024
• Device Model Number: VTICM5_13.2
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 10/20/2023; 10/20/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 05/03/2023; 11/17/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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: Unknown