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

Model Number	VTICM5_13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that 13.7mm vticm5_13.7 -11.50/2.0/110 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient right eye (od) on (b)(6) 2022.The lens was removed on the same day due to sizing (fit too big).A replacement lens of shorter length was implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated that a 13.7mm vticm5_13.7 -11.50/2.0/110 (sphere/cylinder/axis) implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2022.Intraoperatively the lens was removed and replaced with a shorter length lens and the problem resolved.H6-health effect- impact code: 4627 (device explantation) not applicable, patient did not require a corrective invasive procedure to remove the device.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens of diopter -11.5/2.0/110 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2022.The lens was implanted, removed and replaced intraoperatively on the same day with a shorter length lens due to the lens "fit too big".This resolved the problem.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15911065
• Report Number: 2023826-2022-04372
• Device Sequence Number: 17483256
• Product Code: QCB
• UDI-Device Identifier: 00841542118415
• UDI-Public: 00841542118415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: VTICM5_13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 01/09/2024
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 08/18/2023; 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female