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

Model Number VTICMO13.2

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated that as the surgeon attempted to implant a 13.2mm vticmo13.2 implantable collamer lens, -16.0/+1.5/019 (sphere/cylinder/axis) into the patient's right eye (od), the lens became stuck in the cartridge/injection system.This occurred on (b)(6) 2020.An alternate lens was successfully implanted intraoperatively and the problem was resolved.There was no patient contact with the lens and the cause of the event is reported as unknown.

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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 ; 2927902230
• MDR Report Key: 10116211
• MDR Text Key: 194125439
• Report Number: 2023826-2020-01158
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 12/31/2021
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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: 29 YR