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

Model Number	VTICM513.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 of a -6.50/1.0/160 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) 2023, the lens was removed due to excessive vault.Cause of the event is a patient related factor.
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5- the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -6.50/1.0/160 (sphere/cylinder/axis) into the patient's left eye (os) (b)(6) 2023.The patient experienced an excessive vault.On (b)(6) 2023 the lens was explanted.The problem was resolved.Reportedly "we have re-treated the patient and she is doing great".The reporter indicated the cause of the event was a patient related factor.Cause details provided: "between sizes".H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H6: health impact code: "4625 - additional surgery: 'retreated'" should be added.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: 17906060
• Report Number: 2023826-2023-04482
• Device Sequence Number: 7561066
• Product Code: QCB
• UDI-Device Identifier: 00841542116084
• UDI-Public: 00841542116084
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: 04/30/2025
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/26/2024
• Date Device Manufactured: 06/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female