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

Model Number VTICMO12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated a 12.6mm vticmo12.6 implantable collamer lens, -7.50/+1.0/089 (sphere/cylinder/axis), was torn during injection into the patient's left eye (os) and there was no patient contact or injury.The lens was exchanged for another same model/length lens, on (b)(6) 2018 and the problem was resolved.Cause of the event was unknown.

Manufacturer Narrative

Additional data: b5- the reporter indicated that a 12.6mm vticmo 12.6 implantable collamer lens, -7.50/+1.0/089 (sphere/cylinder/axis) got stuck in the cartridge or injection system on 26/04/2018.There was no patient contact or injury.Reportedly "the lens was damaged during the injection." on (b)(6) 2018 a replacement lens of the same model and length was implanted into the patient's left (os) eye and the problem was resolved.Cause of the event is unknown.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, ca ; 3037902237
• MDR Report Key: 10112184
• MDR Text Key: 193637103
• Report Number: 2023826-2020-01149
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

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 Expiration Date: 02/28/2021
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2018
• 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 Age: 38 YR
• Patient Sex: Female