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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated a 13.2mm micl13.2 implantable collamer lens, -7.0 diopter, tore while being loaded and there was no patient contact.The backup lens was implanted with no problem.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
Visual inspection found missing piece of haptic.(b)(4).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Device evaluation: product evaluation found lens returned in liquid in lens case/vial.Visual inspection found no visible damage to lens.A lens work order search was performed.No similar complaints were found.(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: 6813301
• Report Number: 2023826-2017-01366
• Device Sequence Number: 10803830
• Product Code: MTA
• UDI-Device Identifier: 00841542103237
• UDI-Public: 00841542103237
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2017

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: 11/30/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 09/01/2017; 10/23/2017; 10/24/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 09/14/2017; 10/23/2017; 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1