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

Model Number	MICL12.6
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was returned loose in lens tray.Visual inspection found portion of the optic and haptic missing.Clear residue on the lens surface was observed no similar complaints were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a 12.6mm micl12.6 implantable collamer lens, -5.0 diopter, tore during loading.There was no patient contact and the backup lens was implanted.The reporter stated that the cause of the event was unknown.
Additional Manufacturer Narrative
Corrected data: type of report: supplemental #1 was not successfully submitted before supplemental #2.Usage of device: initial report should be "initial use of device" instead of "unknown".Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: concomitant medical products:: injector, cartridge and injector system models are added.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: 6727139
• Report Number: 2023826-2017-01184
• Device Sequence Number: 16389558
• Product Code: MTA
• UDI-Device Identifier: 00841542102926
• UDI-Public: (01)00841542102926(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2017

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: 11/30/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 09/19/2017; 09/19/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/19/2017; 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1