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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned in liquid ,in lens vial.Visual inspection found a missing piece of haptic.One similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that the surgeon had two 13.2mm micl13.2 implantable collamer lenses, -7.0 diopter, that tore during folding.The primary lens had patient contact and the backup lens did not.The reporter stated that the cause of the event could have been due to a loading issue.There was no patient injury and the surgeon decided to implant the backup lens of the opposite eye to complete the surgery.The reporter was not sure which lens was the primary lens that had patient contact because the label was removed with the wrap.

• 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: 6685149
• Report Number: 2023826-2017-01103
• Device Sequence Number: 19326092
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: (01)00841542103237(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/06/2017

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: 04/30/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR