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

Model Number	VTICM513.2
Medical Device Problem Codes	Misfocusing (1401); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -13.0/2.0/82 (sphere/cylinder/axis) was implanted into the patient's left (os) on (b)(6) 2023.On (b)(6) 2023, the lens was exchanged for a longer length lens due to lens rotation not associated to low vault and refractive surprise.The problem was resolved.Cause of the event was user error.
Additional Manufacturer Narrative
A4-a6:unk.H6: user error.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6: 4627-explant.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial with residue/debris on the lens.Visual inspection found the haptic broken and residue on the lens, specifically fibre.Dimensional and functional inspections 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 muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17846529
• Report Number: 2023826-2023-04241
• Device Sequence Number: 11862386
• Product Code: QCB
• UDI-Device Identifier: 00840311311804
• UDI-Public: 00840311311804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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: 08/31/2025
• Device Model Number: VTICM513.2
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/24/2023; 12/21/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 12/20/2023; 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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# 1652251; FOAM TIP PLUNGER - LOT# 1643229; INJECTOR MODEL: MSI-PF - LOT# 1572654
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male