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

Model Number VICMO13.2

Device Problems Crack (1135); Sticking (1597)

Patient Problem Failure of Implant (1924)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusion: based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter indicated the surgeon attempted to insert a 13.2mm vicmo13.2 implantable collamer lens, -09.50 diopter, in the patient's right eye (od) but the lens adhered to the forceps and cracked.There was no patient contact.The surgery was postponed until the next day and another lens was successfully implanted.The surgeon felt there may have been a problem with the lens.

• 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: 5190315
• MDR Text Key: 30333532
• Report Number: 2023826-2015-01404
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2014
• 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: 23 YR