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

Model Number	VTICMO12.6
Medical Device Problem Codes	Misfocusing (1401); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - 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 12.6mm vticmo12.6; -15.50/+3.0/068 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The patient experienced lens rotation not associated with low vaulting; blurry vision.On (b)(6) 2023 the lens was exchanged with a longer length lens and this resolved the problem.The cause of the event was reported as "other" and noted "original calculation & recommended 12.6 sizing too small; = +1- 90 degrees rotation causing blurry vision.
Additional Manufacturer Narrative
Corrected data: health effect - impact code: "4628" should be added.B5- the reporter indicated that the surgeon implanted a 12.6mm vticmo 12.6 implantable collamer lens of diopter -15.50/+3.00/068 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced lens rotation not associated with low vault and blurred vision.On (b)(6) 2023 the lens was repositioned.On (b)(6) 2023 the lens was exchanged with the same model, longer length lens and the problem was resolved.The cause of the event was 'other'.Cause details: "original calculation and recommended (12.6) sizing too small= +/- 90 degrees.Rotation causing blurry vision".Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found haptic torn.Dimensional inspection will not be performed due to significant haptic damage.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: 16839441
• Report Number: 2023826-2023-01568
• Device Sequence Number: 7547910
• Product Code: QCB
• UDI-Device Identifier: 00841542120470
• UDI-Public: 00841542120470
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 04/13/2023

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: 08/31/2024
• Device Model Number: VTICMO12.6
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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#-1585269; FOAM TIP PLUNGER MODEL-FTP, LOT#-1632183; INJECTOR MODEL-MSI-PF, LOT#- 1522339
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female