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

Model Number TMICL13.2

Device Problem Ejection Problem (4009)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

Lens work order search: one similar complaint type event reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that as the surgeon was attempting to implant a 13.2mm tmicl13.2 implantable collamer lens, -15.5/+3.0/089 (sphere/cylinder/axis) into the patient's right eye (od), the footplates of the lens got stuck in the injector.There was no patient contact with the lens.An alternate lens was successfully implanted; "all went well with patient interactions".

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 8452984
• MDR Text Key: 139896862
• Report Number: 2023826-2019-00483
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542109826
• UDI-Public: 00841542109826
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2019

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: 01/31/2021
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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: 27 YR