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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vticm5_12.6 implantable collamer lens of -9.50/1.5/113 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2023.Low vault was observed, lens remains implanted.Cause of event was unknown.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that a 12.6mm vticm5_12.6 implantable collamer lens of -9.50/1.5/113 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6)2023.Low vault without rotation was observed.On (b)(6) 2023 the lens was exchanged with a lens of longer length and different power.This exchange resolved the problem.The cause of event was reported as unknown.Claim#: (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that a 12.6mm vticm5_12.6 implantable collamer lens of -9.50/1.5/113 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6)2023.Low vault without rotation and refractive surprise was observed.On (b)(6) 2023, the lens was exchanged with a lens of longer length and different power.This exchange resolved the problem.The cause of event was reported as unknown.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: 18353416
• Report Number: 2023826-2023-05705
• Device Sequence Number: 8425322
• Product Code: QCB
• UDI-Device Identifier: 00840311308095
• UDI-Public: 00840311308095
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2023

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: 03/31/2026
• 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: 11/22/2023
• Supplement Date Received by Manufacturer: 01/04/2024; Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 04/10/2024; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female