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

Model Number	VTICM5 13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -9.00/1.0/173 (sphere/cylinder/axis) was implanted into the patient's right eye (od).On (b)(6) 2023 the lens was implanted and removed intra-op due to excessive vault; refractive surprise; pupil block with elevated iop; and angle closure with elevated iop.On the same day different surgery a replacement lens was implanted and the problem was not resolved.Cause reported as device.See mfr# 2023826-2024-00047 for replacement lens.
Additional Manufacturer Narrative
H6-clinical code 4581: angle closure with elevated iop.Investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b1- adverse event.B5-the reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -9.00/1.0/173 (sphere/cylinder/axis) was implanted into the patient's right eye (od).On (b)(6)2023 the lens was implanted and removed intra-op due to excessive vault; refractive surprise; pupil block with elevated iop; and angle closure with elevated iop.On (b)(6) 2023 a replacement lens was implanted and the problem was not resolved.Cause reported as device.See mfr# 2023826-2024-00047 for replacement lens.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -9.00/1.0/173 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2023.Excessive vault; pupil block with elevated iop, and angle closure with elevated iop was reported.On (b)(6) 2023, the lens was explanted and on the same day a replacement lens was implanted.The replacement lens did not resolve the problem due to surgeon implanting the wrong lens into the patients eye.See mfr#: 2023826-2024-00047 for replacement lens.H10: clinical code 2137 in initial mdr is no applicable.Device code 1401 in initial mdr is not applicable.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: 18440465
• Report Number: 2023826-2024-00046
• Device Sequence Number: 12500075
• Product Code: QCB
• UDI-Device Identifier: 00840311311163
• UDI-Public: 00840311311163
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2023

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: 04/30/2026
• Device Model Number: VTICM5 13.2
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 01/02/2024; 02/27/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/03/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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 (FTP), LOT# UNK.; INJECTOR MODEL: MSI-TF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male