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

Model Number MICL12.6

Device Problems Sticking (1597); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

Lens and injection system not returned.Method - work order search, cartridge lot number search results - a lens work order search was performed and no similar complaints were found within the work order.A cartridge lot number search was performed and one other complaint was found.Conclusion - based on the complaint history, lens work order search and cartridge lot number search, a specific root cause of the event could not be determined.(b)(4).Lens and injection system not returned.

Event Description

The reporter stated the surgeon attempted to load a 12.6mm micl12.6 implantable collamer lens, -10.5 diopter, into the sfc-45 fp cartridge, but the lens appeared to be stuck and tore.The surgeon didn't know if the event was due to the lens or cartridge.There was no patient contact and the backup lens was implanted with no problem.See mfr.2023826-2015-01220 for the cartridge.

Manufacturer Narrative

Evaluation of the returned product found a piece of one haptic torn off and missing.The lens was returned in liquid.Based on the complaint history, work order search, cartridge lot search and the evaluation of the returned product, a specific root cause of the event could not be determined.(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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5079603
• MDR Text Key: 25882651
• Report Number: 2023826-2015-01215
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2015

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: 05/31/2016
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2015
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2014
• 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