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

Model Number TMICL13.2

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon inserted and removed a 13.2mm tmicl13.2 implantable collamer lens, - 12.50/+2.0/106 (sphere/cylinder/axis), from the patients right eye (od), within the same surgery due to the lens unfolded incorrectly in the eye.There was no patient injury and the backup lens was implanted with no problem, the problem was resolved.The patient is doing well.The cause of the event was unknown.

• 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 9492306
• MDR Text Key: 190129599
• Report Number: 2023826-2019-02398
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542109383
• UDI-Public: 00841542109383
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/19/2019

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: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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