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

Model Number	VTICMO13.2
Medical Device Problem Codes	Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -6.0/1.5/083 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6)2022.The lens was intraoperatively implanted, removed, and replaced with the replacement lens due to a lens tear/break during injection delivery into the eye and refractive surprise.The problem was resolved.Cause of the event is unknown.
Additional Manufacturer Narrative
Weight/ ethinicity/ race:unk work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: based on corrected additional information from the reporter, refractive surprise was not observed.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b1: adverse event should be corrected to product problem.B2: outcomes attributed to adverse event- should be omitted for correction.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: 26-nov-2022 should be corrected to 26-nov-2020.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: 16024296
• Report Number: 2023826-2022-04693
• Device Sequence Number: 15193612
• Product Code: QCB
• UDI-Device Identifier: 00840311311781
• UDI-Public: 00840311311781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 11/22/2022

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: 09/30/2023
• Device Model Number: VTICMO13.2
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 02/06/2023; 02/28/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 12/29/2022; 02/27/2023; 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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: 34 YR
• Patient Sex: Male