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 Date 09/04/2023

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6, -14.00/+1.00/133 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2020.The surgeon reports the patient has uveitis which was noted (b)(6) 2023.Lens remains implanted.The cause of the event was reported as unknown.

Manufacturer Narrative

H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

Additional data: b5- the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -14.0/+1.0/133 (sphere/cylinder/axis) into the left eye (os) in (b)(6)2020.The patient experienced uveitis in (b)(6) 2023.Reportedly "there is no history about uveitis previous icl implantation.After the implantation in (b)(6) 2020 there was a good outcome.Good vaulting ~ 600, normal iop and ucva 20/20.The patient was happy.About 6 month ago there occur an uveitis only at the left eye.At this time there was no intake or conversion of systemic or local medications.There were a lot of medical check-ups in different kind of specialization with no reason for the uveitis.Now the surgeon plans a lens exchange at this eye".On (b)(6) 2024 the lens was explanted.The reporter indicated the cause of the event is unknown.D6b."(b)(6) 2024" should be added.H6- health effect- impact code: "4627" should be added and "4614" should be removed.H6- type of investigation code: 3331- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17777436
• MDR Text Key: 323784872
• Report Number: 2023826-2023-04124
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2023

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 Expiration Date: 06/30/2020
• 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: 09/04/2023
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• 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 MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female