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

Model Number VTICH12.6

Device Problems Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2016

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon attempted to insert a 12.6mm vtich12.6 implantable collamer lens, 5.0/+2.5/093 diopter, and the lens tore/broke before injection into the eye.The lens was not implanted.

Manufacturer Narrative

Additional information received - the reporter indicated there was no patient contact and the problem was resolved by implanting another lens.The reporter indicated the cause of the event was due to technique error/surgeon mishandling.(b)(4).

Manufacturer Narrative

The lens was returned in liquid in a lens case/vial.Visual inspection found the haptic broken.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6091609
• MDR Text Key: 59562960
• Report Number: 2023826-2016-01629
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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,Followup,Followup
• Report Date: 10/13/2016

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: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: VTICH12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2016; 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2015
• 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: 24 YR