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

Model Number	VTICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6:unk.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 of a -7.0/1.5/012 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's eye.The lens was removed and replaced.
Additional Manufacturer Narrative
B5: lens was implanted into the patient's right eye (od) on (b)(6) 2023.Excessive vault is observed.The lens was removed and the patient is awaiting replacement.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -7.00/1.5/012 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault.On (b)(6) 2023 the lens was explanted.Reportedly "ordered smaller size.Pending new lenses." the cause of the event was a patient related factor.Cause details provided: "between sizes." d6a."(b)(6) 2023" should be added.D6b."(b)(6) 2023" should be added.Health effect impact code: "4629" should be removed and "4627" 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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17664989
• Report Number: 2023826-2023-03783
• Device Sequence Number: 6324619
• Product Code: QCB
• UDI-Device Identifier: 00841542116169
• UDI-Public: 00841542116169
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/11/2023

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: 12/31/2024
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 10/09/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/09/2023
• Date Device Manufactured: 01/10/2023
• 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