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

Model Number VICMO12.6

Device Problems Defective Device (2588); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

This product was manufactured in the u.S.But is not marketed in the u.S.Diopter: -11.00.(b)(4).Method: lens work order search.Results: a lens work order search revealed no similar complaint within the work order.Conclusions: conclusion not yet available.Evaluation is in progress.(b)(4).

Event Description

The reporter indicated the surgeon attempted to use a 12.6mm vicmo12.6, -11.00 diopter implantable collamer lens.Before opening the lens vial, a scratch was found on the lens.Lens was received with scratch.Then when taking out the lens from the vial with forceps, it was torn in two pieces and one piece was lost.There was no patient contact.

• 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5227492
• MDR Text Key: 31329208
• Report Number: 2023826-2015-01416
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2015
• 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