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)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -8.5/2.0/130 (sphere/cylinder/axis) was implanted in the patient's left eye (os) on (b)(6) 2022.Refractive change overtime was observed.Cause of the event was user error.Reportedly, "surgeon used wrong datas for calculation in ocos, data for od used for os.
Additional Manufacturer Narrative
Corrected data: b1: adverse event should have been product problem in the original mdr submission.B2: required intervention to prevent permanent impairment/damage should have been omitted from the original mdr submission.B5: refractive change over time should be corrected to state refractive surprise.Additional information: b5: the reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -8.5/2.0/130 (sphere/cylinder/axis) was implanted in the patient's left eye (os) on (b)(6) 2022.Refractive surprise was observed.Cause of the event was user error.On (b)(6) 2022 the lens was replaced with a same length but different model and diopter lens.Reportedly, "surgeon used wrong data for calculation in ocos, data for od used for os.D6b: explant date: on (b)(6) 2023.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: 16117774
• Report Number: 2023826-2023-00054
• Device Sequence Number: 6867331
• Product Code: QCB
• UDI-Device Identifier: 00840311311712
• UDI-Public: 00840311311712
• 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
• Device Explanted 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
• Report Date (Section B): 12/10/2022

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: 08/31/2025
• 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: 12/10/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/20/2023
• 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: 22 YR
• Patient Sex: Male