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

Model Number VTICM5 13.7

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

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Lens work order search: no similar complaint event(s) within associated lots were found.Claim #: (b)(4).

Event Description

The reporter indicated that a 13.7mm vticm5 13.7 implantable collamer lens of -8.5/1.0/071 (sphere/cylinder/axis) got stuck in cartridge or injection system.The lens was not implanted into the patient but it did have patient contact with no patient injury.Reportedly "on the right eye, after successful loading, the lens was visualized to be upside down in the cartridge after 1/4 of the lens was injected out.He didn't complete the lens injection, and instead removed the cartridge tip from the incision and injected the lens onto the sterile field.One of the foot plates was visualized to be caught under the plunger silicone tip.The back-up lens was opened and loaded into a new lioli and cartridge, and implanted into the eye without complication." cause reported as device; "three lioli plastic injector arms were visibly warped from the same box.Doctor previously had an injector event on (b)(6)2022.I was not present at the time of that event, but dr.(b)(6) confirmed the injectors were from the same box.".

• 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: 16019649
• MDR Text Key: 308478063
• Report Number: 2023826-2022-04430
• Device Sequence Number: 1
• Product Code: QCB
• 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
• Report Date: 11/21/2022

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 13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2022
• 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
• Treatment: INJECTOR MODEL: LIOLI-24, LOT #: FCJ0702
• Patient Sex: Female