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

Model Number MICL13.2

Device Problems Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

Work order search, injector lot search, cartridge lot search, foam tip plunger lot search.A lens work order search was performed and no similar complaints were found.An injector lot search found another similar complaint.A cartridge lot search found another similar complaint.A foam tip plunger lot search found another similar complaint.Based on the complaint history, lens work order search, injector, cartridge and foam tip plunger lot searches, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter indicated a 13.2mm micl13.2 implantable collamer lens , -12.5 diopter, tore during the loading process and there was no patient contact.The reporter indicated the event was not due to user error.This was one of two lenses used for this patient - see mfr.Report # 2023826-2016-00036.Another same model lens, but different diopter power 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

Method: device history record review.Results: based on the dhr review and root cause analysis, the probable cause could not be determined at this time.There were no documented issues and concerns with the manufacturing and inspection processes which may cause damage to the lens.Physician report does not indicate that any adverse event or condition would have caused damage to the lens.Conclusion: based on the complaint history, work order search, product evaluation, injector lot search, cartridge lot search, foam tip plunger lot search, 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5365485
• MDR Text Key: 36277058
• Report Number: 2023826-2016-00037
• 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: Initial,Followup
• Report Date: 12/14/2015

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: 04/30/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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