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

Model Number	MICL13.7
Medical Device Problem Codes	Entrapment of Device (1212); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in a lens case/vial.Visual inspection found a piece of haptic missing.Work order search: no similar complaints types events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon attempted to implant a micl13.7,-10.0 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2017.The surgeon could not advance the lens in the injector.The surgeon believed that the lens could have been damaged and cause it to be stuck.There was no patient contact with the device.During the same surgery; a back-up lens was used and it was successful.
Additional Manufacturer Narrative
Corrected data: date of birth corrected from (b)(6) to (b)(6).Type of reportable event corrected from serious injury to malfunction.Device evaluation: product evaluation found that the lens was returned in liquid in a lens case/vial.Visual inspection found the lens missing pieces of its haptic.(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: 7069171
• Report Number: 2023826-2017-01796
• Device Sequence Number: 1300535
• Product Code: MTA
• UDI-Device Identifier: 00841542103565
• UDI-Public: 00841542103565
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 11/01/2017

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: 01/31/2019
• Device Model Number: MICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR