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

Model Number	VTICM512.6
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -9.0/1.0/095 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.On (b)(6)2022, the lens was exchanged for a shorter length lens due to excessive vault.The problem was not resolved.Reportedly, "icl os was to be exchanged for a smaller lens, however after explantation of original lens, new lens was unable to be implanted due to floppy iris and possible zonular insufficiency." cause of the event is unknown.
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -9.0/1.0/095 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to excessive vault.The problem was resolved.Reportedly, "icl os was to be exchanged for a smaller lens, however after explantation of original lens, new lens was unable to be implanted due to floppy iris and possible zonular insufficiency." h6: 1494-off label: age<21 years old at the time of implantation.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 ; 8002927902
• MDR Report Key: 16330097
• Report Number: 2023826-2023-00397
• Device Sequence Number: 12340948
• Product Code: QCB
• UDI-Device Identifier: 00841542114820
• UDI-Public: 00841542114820
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: VTICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female