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

Model Number	VTICM5_12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that while attempting to implant a 12.6mm vticm5_12.6; -6.50/3.0/096 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os), it was indicated that the lens had flipped upside down.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: one similar complaint type events reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that while attempting to implant a 12.6mm vticm5_12.6; -6.50/3.0/096 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) it was indicated that the lens had also flipped upside down and had elevated iop.The lens was implanted and removed intraoperatively within the initial surgery.On 18/12/2023 the lens was replaced with a same model and length lens.Reportedly, the cause of this event was marked as "device", "user error" and yes the device failed to perform as intended.Cause details provided "during icl implantation, the icl did not unfold properly, but folded sideways on itself.Attempts to use viscoelastic to unfold the lens in the proper orientation were unsuccessful.This occurred twice".This did not resolve the problem.See mdr # 2023826-2024-00062.For replacement lens 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
• MDR Report Key: 18428693
• Report Number: 2023826-2024-00061
• Device Sequence Number: 7731561
• Product Code: QCB
• UDI-Device Identifier: 00840311308873
• UDI-Public: 00840311308873
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: VTICM5_12.6
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Unknown