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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned in liquid, in lens case/vial.Visual inspection found a piece of haptic missing.No similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -10.0 diopter, in the patients right eye and noticed the lens was torn.Portion of the lens haptic was found in the delivery device.The incision was enlarged to 3.2mm to remove the lens, no sutures were required.The reported stated that the delivery system ejected the lens slower than usual but that the cause of the event was unknown.The backup lens was implanted with no issues, the patient left the operating room in good condition.
Additional Manufacturer Narrative
Corrected data: the device was returned to manufacturer on 03-jul-2017.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6678860
• Report Number: 2023826-2017-01066
• Device Sequence Number: 43327
• Product Code: MTA
• UDI-Device Identifier: 00841542103022
• UDI-Public: (01)00841542103022(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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
• Operator of Device: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR