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

Model Number MICL12.6

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter stated the surgeon loaded a 12.6mm micl12.6 implantable collamer lens, -9.5 diopter, and noted after pulling the lens down the cartridge barrel, a piece of the lens was protruding out of the cartridge.He wasn't sure if he could inject the lens correctly into the eye, so he ejected the lens onto the sterile field, with the plan of reloading the lens.After examining the lens, he noted one haptic was slightly bent, so he decided not to use this lens.There was no patient contact and the backup was implanted with no problem.The patient is doing very well.The surgeon stated the cause of the event was unknown but occasionally when he is pulling the lens down the cartridge barrel, he finds it hard to release the lens with the forceps.

Manufacturer Narrative

Event problem and evaluation codes: method code(s): (process evaluation): device history record review.Result code(s): (operational problem) : visual inspection of the returned product found no visible damage.The lens was returned in liquid.(no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion code(s): (unable to confirm complaint): based on the complaint history, work order search, device history record review and product evaluation, 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5648755
• MDR Text Key: 44995377
• Report Number: 2023826-2016-00640
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103015
• UDI-Public: (01)00841542103015(17)171031
• 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: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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