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

Model Number VTICMO12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vticmo12.6 implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2022.Observation of low vault with rotation, elevated iop, glare/haloes, blurred vision and mild dilated pupil was reported.Lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Claim#: (b)(4).

Manufacturer Narrative

Additional information: b5: on (b)(6) 2022 the lens was repositioned.This did not resolve the problem.D4: sn# (b)(6).Expiration date: 31/oct/2024.Manufacture date: 04-dec-2021.Claim# (b)(4).

Manufacturer Narrative

Additional information: reportedly, the doctor decided not to remove the icl.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: 18744472
• MDR Text Key: 336464038
• Report Number: 2023826-2024-00733
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 05/13/2024
• Supplement Dates FDA Received: 03/28/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2021
• 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 W/FTP, LOT #: UNK.; INJECTOR MODEL: MSI-TF, LOT #: UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male