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

Model Number MICL12.1

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer? no, lens not returned.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).Lens not returned.

Event Description

The reporter stated the surgeon inserted a 12.1mm micl12.1 implantable collamer lens, -13.0 diopter, but when the surgeon attempted to tuck the haptics, the surgeon noted the haptics were covering the peripheral iridotomies.The lens was removed within the same surgery with no patient injury.The lens was torn upon removal.The backup lens was implanted with no problem.

Manufacturer Narrative

Per medical review - malposition of the haptics could be due to patient anatomy, pathology such as ciliary cysts, fault in lens manufacture, or due to surgeon handling.Visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.Based on the complaint history, work order search, medical review and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Method: device history record review results: upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records to suggest a contributory factor to the complaint.Conclusion: based on the complaint history, work order search, product evaluation, medical review, and device history record review, a specific root cause of the event could not be determined.Claim #(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: 5125127
• MDR Text Key: 27416687
• Report Number: 2023826-2015-01320
• 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: Other
• Type of Report: Followup,Followup
• Report Date: 09/04/2015

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: 07/31/2016
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/16/2015; 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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: 28 YR