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

Model Number VTICM5 13.2

Device Problems Unintended Movement (3026); No Apparent Adverse Event (3189); Ejection Problem (4009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim#(b)(4).

Event Description

The reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -12.50/3.5/089 (sphere/cylinder/axis) lens tore/broke during injection into the eye on (b)(6)2022.The lens was not implanted into the patient but it did have patient contact with no patient injury.Reportedly the doctor stopped and restarted injecting due to the injector resistance and that probably did not help.On the same day same surgery the backup lens was implanted and the problem was resolved.Status of the eye." doing great, showing slightly more cyl than expected but it's still early." cause reported as device and user error.

Manufacturer Narrative

Corrected data: b5- the reporter indicated that a 13.2mm vticm5_ 13.2 implantable collamer lens of diopter -12.50/3.5/089 (sphere/cylinder/axis) got stuck in the cartridge/injection system; then the lens was implanted upside down on (b)(6)2022.Reportedly the surgeon "did not like how the primary lens looked when trying to implant it".There was patient contact but no patient injury.The lens was implanted; removed and replaced intraoperatively with a back up lens of the same model/length lens and the problem was resolved.Reportedly the lens tore/broke when the doctor removed the lens.The status of the eye was reported as "doing great; showing significantly more cyl than expected but it's still early".The reporter indicated the cause of the event was the device/user error and the device failed to perform as intended.Reportedly "i stopped and restarted injecting due to injector resistance and that probably didn't help".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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15740042
• MDR Text Key: 306914610
• Report Number: 2023826-2022-03864
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542116978
• UDI-Public: 00841542116978
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10/05/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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 Age: 24 YR
• Patient Sex: Female