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

Model Number	VTICM512.1
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -11.0/2.0/074 (sphere/cylinder/axis) was implanted into the patient's eye.On (b)(6) 2022, the lens was exchanged due to the lens being too small and lens rotation.
Additional Manufacturer Narrative
Corrected data b5: the reporter indicated that a 12.1mm vticm512.1 implantable collamer lens of -11.0/1.5/086 (sphere/cylinder/axis) was implanted into the patient's eye on (b)(6) 2022.On (b)(6) 2022, the lens was exchanged for a longer length lens due to the lens being too small and lens rotation.Reportedly, "iop was good." claim# (b)(4).
Additional Manufacturer Narrative
B5: corrected to: the reporter indicated that a 12.1mm vticm512.1 implantable collamer lens of -11.0/1.5/086 (sphere/cylinder/axis) was implanted into the patient's eye on (b)(6) 2022.On (b)(6) 2022, the lens was explanted and replaced for a longer length lens due to the lens being too small and lens rotation.Reportedly, "iop was good." h6 - health effect - impact code: 4627 should be added to initial mdr.H6 - health effect - impact code: 4629 should be removed from the initial mdr.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: 16065464
• Report Number: 2023826-2022-04738
• Device Sequence Number: 2034040
• Product Code: QCB
• UDI-Device Identifier: 00841542113502
• UDI-Public: 00841542113502
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 11/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: VTICM512.1
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 02/22/2023; 02/27/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/22/2023; 02/27/2023
• Date Device Manufactured: 06/17/2022
• 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: Unknown