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

Model Number VICM5_13.2

Device Problems Difficult or Delayed Positioning (1157); Device Operates Differently Than Expected (2913)

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

Event Date 07/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon inserted a 13.2mm vicm5_13.2 implantable collamer lens, -14.00 diopter, and the lens tore/broke during injection into the eye.The lens was removed within the same surgery, with no report of any patient injury.Another same model but different diopter lens was implanted and the problem was resolved.The reporter indicated when the lens was injecting into the eye, the lens became trapped between the foam tip plunger and the cartridge tip and would not release.

Manufacturer Narrative

Device evaluation: the lens was returned dry in a micro centrifuge vial.Visual inspection found one haptic bent and a piece of the other haptic torn off and missing.There was evidence of clear residue on the lens.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: 6772663
• MDR Text Key: 82029609
• Report Number: 2023826-2017-01252
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2020
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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: 33 YR