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

Model Number	VTICM513.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -8.5/1.5/099 (sphere/cylinder/axis) was implanted in the patient's left eye (os) on (b)(6) 2022.Refractive change was observed.Cause of the event is unknown.
Additional Manufacturer Narrative
Patient information:unk.Work order search found no similar complaints.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5- on (b)(6) 2023 the lens was repositioned.The lens remains implanted and the problem was not resolved.Additional information provided: "repositioning of the lens by prof.Parasta was not successful.Patient is wearing glasses again.Cole monitoring.If the patient want a lens exchange the surgeon would like to explant the current lens.Wait for 3 months and then remeasure the eye and recalculate the lens for exchange.We will keep you updated".The cause of the event as unknown.Claim# (b)(4).
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a 13.2mm vticm5 13.2 implantable collamer lens of diopter-8.5/+1.5/099 (sphere/cylinder/axis) into the left eye (os) on (b)(6) 2023.The patient experienced a refractive surprise.The lens remains implanted.The cause of the event is unknown.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: 16678777
• Report Number: 2023826-2023-01181
• Device Sequence Number: 3614505
• Product Code: QCB
• UDI-Device Identifier: 00840311311439
• UDI-Public: 00840311311439
• 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
• Report Date (Section B): 03/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: VTICM513.2
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 06/08/2023; 06/29/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/08/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: 34 YR
• Patient Sex: Female