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

Model Number	MICL12.6
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: lens was returned dry in a specimin cup.There was clear surgical residue/debris on the product and lens surface.Visual inspection found the haptic torn.Work order search: one similar complaint type reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that on (b)(6) 2017 as the surgeon attempted to implant a 12.6mm micl12.6 implantable collamer lens, diopter -7.0, into the patient's left (os) eye, it got stuck to the plunger and the lens broke.There was no patient contact with the lens; back-up lens inserted during the same surgery.
Additional Manufacturer Narrative
Attempted implant date should be (b)(6) 2017.Claim# (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: 6864973
• Report Number: 2023826-2017-01458
• Device Sequence Number: 565999
• Product Code: MTA
• UDI-Device Identifier: 00841542102964
• UDI-Public: 00841542102964
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR