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

Model Number	VTICM513.7
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
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 13.7mm vticm513.7 implantable collamer lens of -12.0/2.0/94 (sphere/cylinder/axis) was implanted as a replacement into the patient's right eye (od) on (b)(6) 2023, due to low vault without rotation.The problem was not resolved.Status of the eye is "ok." cause of the event is unknown.It was reported that the resulting vault is still very low.
Additional Manufacturer Narrative
Date of event: "18-oct-2023" should be removed.The reporter indicated that the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens of diopter -12.0/+2.0/094 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023 as a replacement lens.The patient experienced a low vault.Reportedly "the resulting vault is still very low".The lens remains implanted.It was later reported "the patient is fine, they will be monitored during their annual check-ups, but no further adjustments can be made with icl since there are no more sizes available".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. suite210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18151101
• Report Number: 2023826-2023-05086
• Device Sequence Number: 12180253
• Product Code: QCB
• UDI-Device Identifier: 00840311315147
• UDI-Public: 00840311315147
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/08/2023

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 Expiration Date: 04/30/2026
• Device Model Number: VTICM513.7
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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
• Patient Age: 32 YR
• Patient Sex: Male