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

Model Number MICL12.6

Device Problem Difficult to Insert (1316)

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

Event Date 05/19/2015

Event Type  malfunction  

Event Description

The reporter indicated the surgeon was inserting a 12.6mm micl12.6 implantable collamer lens but the lens appeared to be stuck and only came half way out of the cartridge.The lens touched the patient's eye but was not fully inserted.The surgeon implanted the backup lens with no problem, using a new injector, cartridge and foam tip plunger.The reporter indicated the surgeon felt the event was due to an overly used injector and the foam tip plunger, which was not connected properly by the technician.The surgeon did not feel there was a problem with the lens or injection system.

Manufacturer Narrative

(b)(4)- no known impact or consequence to patient; difficult to insert.Evaluation 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 no similar complaints were found.Visual inspection of the returned product found dried surgical residue on the lens surface and was unable to detect any damage to the lens.An sfc-45 fp cartridge was returned with no visible damage, there was evidence of clear surgical residue.The injector and foam tip plunger were not returned.Conclusions: based on the complaint history, work order search, cartridge lot number search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

There is no information to determine the cause of incomplete egress of the lens from the cartridge, or if it was due to improper lens loading or surgeon handling.A cartridge lot number search showed no similar complaints.Based on the complaint history, work order search, medical review, cartridge lot number 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 AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer (Section G): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4842043
• MDR Text Key: 21062151
• Report Number: 2023826-2015-00667
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

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: 07/31/2015
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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
• Treatment: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER 1309059; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK
• Patient Age: 26 YR