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

Model Number VTICM5 12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uveitis (2122)

Event Type  Injury  

Event Description

Inflammatory reaction 9 days after implantable collamer lens implantation was reported.Rporter is uncertain of the etiology but is treating it as uveitits.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Claim#: (b)(4).

Manufacturer Narrative

The reporter indicated that a 12.6mm vticm5_12.6 -7.0/2.0/072 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's left eye on (b)(6) 2023.Uveitis was reported.Lens was explanted on (b)(6) 2023.Investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.(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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18164007
• MDR Text Key: 328441105
• Report Number: 2023826-2023-05151
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542114561
• UDI-Public: 00841542114561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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
• Patient Outcome(s): Required Intervention