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

Model Number MICL13.7

Device Problems Device Slipped (1584); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

Method (process evaluation): work order search.Results (evaluation result): a lens work order search was performed and no similar complaints were found within the work order.Conclusion (unable to confirm complaint): 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 stated the surgeon inserted a 13.7mm micl13.7 implantable collamer lens, -8.0 diopter and the lens "slid out" of the patient's eye.The backup lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Results (evaluation result): visual inspection of the returned product found a piece of one lens haptic torn off and missing.The lens was returned in liquid.Conclusion (unable to confirm complaint): based on the complaint history, work order search and 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, medical review.Results: a review of the device history record was performed and nothing was found in the manufacturing and packaging processes of this lens that could be identified as the cause of the complaint.The cause of the lens to slip out of the eye, is possibly due to improper loading or handling practices in the operating room.Per medical review - reportedly, lens "slid out " of the eye requiring intraoperative lens exchange.No reported incision enlargement or any other tissue damage.The backup lens was successfully implanted.Given the information about the lens that slipped out of an eye it is very likely that user error (premature lens injection) have caused/contributed to the event.Conclusion: based on the complaint history, work order search, device history record review, medical review and the evaluation of the returned product, it is very likely that user error (premature lens injection) have caused/contributed to the event.(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: 5248526
• MDR Text Key: 32215379
• Report Number: 2023826-2015-01474
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2015

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: 11/30/2016
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/24/2015; 02/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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: 46 YR