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

Model Number MICL13.2

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Visual inspection showed a piece of one haptic was torn off and missing.The lens was returned in liquid.(b)(4).

Event Description

The reporter stated the surgeon loaded a 13.2mm micl13.2 implantable collamer lens, -8.0 diopter, on (b)(6) 2016 and noticed the lens was scratched as he was attempting to insert the lens in the patient's eye.The cause of the event was unknown.There was no patient contact.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, 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: 5710174
• MDR Text Key: 47122356
• Report Number: 2023826-2016-00804
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 32 YR