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

Model Number MICL12.6

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

Results (operational problem): visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.(b)(4).

Event Description

The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -8.5 diopter, and the lens would not unfold in the patient's eye.The lens was removed with no patient injury and the backup lens was implanted.

Manufacturer Narrative

Method: (process evaluation): device history record review.Result: (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5693629
• MDR Text Key: 46360263
• Report Number: 2023826-2016-00796
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542102995
• UDI-Public: (01)00841542102995(17)171130
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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
• Patient Age: 41 YR