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

Model Number VICMO13.2

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Torn Material (3024)

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

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon inserted a 13.2mm vicmo13.2 implantable collamer lens, -09.50 diopter, in the patient's left eye (os) and the lens tore/broke during delivery into the eye.The lens was removed with no apparent injury.

Manufacturer Narrative

Device evaluation: product evaluation found that the lens was returned dry in lens case/vial with clear surgical residue/debris on product.Visual inspection found that haptic was broken.Conclusion code: as per the dfu of this lens model, implantation of lens in an eye with an anterior chamber depth (acd), as measured from the corneal endothelium to the anterior lens capsule, less than 3.0mm is contraindicated.This patient had an acd of 2.92mm at the time of implantation.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• 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: 5831912
• MDR Text Key: 50728288
• Report Number: 2023826-2016-00923
• Device Sequence Number: 1
• Product Code: MTA
• 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,Followup
• Report Date: 06/28/2016

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: 09/30/2018
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• 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: 21 YR