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)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of a -14.0/3.0/91 (sphere/cylinder/axis) tore/broke during injection/delivery into the eye on (b)(6) 2024.The reporter stated that the lens was stuck in the plunger.There was patient contact.There was no patient injury.On (b)(6) 2023, a replacement lens was implanted into the patient's right eye (od).The problem was resolved.Status of the eye is reported as quiet.

• 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 ; 8002927902
• MDR Report Key: 18705589
• Report Number: 2023826-2024-00635
• Device Sequence Number: 17729872
• Product Code: QCB
• UDI-Device Identifier: 00840311312382
• UDI-Public: 00840311312382
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 02/06/2024
• Initial Report FDA Received Date: 02/14/2024
• Date Device Manufactured: 11/30/2023
• 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; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL - MSI-PF - LOT# UNK
• Patient Age: 21 YR
• Patient Sex: Female