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

Model Number MICL12.6

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

Pt age and weight: unk.Method - 3331 (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.Visual inspection of the returned product found no visible damage to the lens.The lens was returned dry and there was evidence of clear surgical residue.The cartridge and injector were returned with no visible damage to either device.There was evidence of clear surgical residue.Conclusion: (unable to confirm complaint): based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -11.5 diopter, but the lens unfolded and was only partially inserted.The lens was removed with no patient injury.The backup lens was implanted with no problem.

Manufacturer Narrative

Method: device history record review, medical 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.Reportedly, micl was only partially inserted in the eye when the surgeon observed unexpected unfolding and decided to remove/exchange the lens.No report of incision enlargement or any other tissue damage.Another lens was successfully implanted.According to the report by a nurse, dated on (b)(6) 2015, the cause of the event was unknown.The same report stated that there was no patient injury during removal of a damaged lens.No reported postoperative sequelae.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.(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: 5248830
• MDR Text Key: 32234113
• Report Number: 2023826-2015-01574
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

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: 07/31/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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