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

Model Number VTICM5 13.2

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/06/2023

Event Type  Injury  

Event 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.

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).

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).

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)
• Type of Device: 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
• MDR Text Key: 331859948
• Report Number: 2023826-2024-00046
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311311163
• UDI-Public: 00840311311163
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: VTICM5 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/02/2024; 02/27/2024
• Supplement Dates FDA Received: 01/03/2024; 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45: LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-TF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male