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

Model Number	VTICM512.6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -9.0/1.5/075 (sphere/cylinder/axis) was implanted in the patient's right eye (od) on (b)(6)2022.Reportedly, "wrong sign in the cylinder in the calculation." cause of the event was user error.Lens remains implanted.
Additional Manufacturer Narrative
Corrected data: b1: should be corrected to malfunction.B2: should be omitted for correction.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: the patient does not want a lens exchange.A laser enhancement is planned for the summer.Claim# 727633.
Additional Manufacturer Narrative
B1: should be corrected to adverse event.B2: should be corrected to required intervention to prevent permanent impairment/damage.B5: should be corrected to: the reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -9.0/1.5/075 (sphere/cylinder/axis) was implanted in the patient's right eye (od) on (b)(6) 2022.Reportedly, "wrong sign in the cylinder in the calculation." cause of the event was user error.On (b)(6) 2022 the lens was repositioned and this did not resolve the problem.Reportedly, "the patient does not want a lens exchange.A laser enhancement is planned for the summer".Lens remains implanted.H1: should be corrected to serious injury.(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: 16153693
• Report Number: 2023826-2023-00108
• Device Sequence Number: 15204833
• Product Code: QCB
• UDI-Device Identifier: 00840311308088
• UDI-Public: 00840311308088
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/16/2022

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: 07/31/2025
• Device Model Number: VTICM512.6
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 04/06/2023; 05/03/2023; 07/31/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 04/06/2023; 05/31/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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: CARTRIDGE MODEL - SFC-45 - LOT# UNK; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female