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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid, in a vial.Visual inspection found a piece of lens haptic torn off and missing.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -12.0 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted due to vaulting.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Additional information received: the lens was removed due to low vaulting.A new lens of longer length was implanted on (b)(6) 2017.Method code: no similar complaint type events were found within the associated lot.(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: 7065636
• Report Number: 2023826-2017-01799
• Device Sequence Number: 19170355
• Product Code: MTA
• UDI-Device Identifier: 00841542103060
• UDI-Public: 00841542103060
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR