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

Model Number	MICL13.7
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	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated the surgeon had trouble loading a 13.7mm micl13.7 implantable collamer lens, -9.5 diopter, and the lens was damaged.There was no patient contact and the backup lens was used.The lens was discarded.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The lens was in the process of being pulled forward into the cartridge tip when a piece of the icl was torn off between the leading footplates by the forceps.The icl, cartridge and forceps were replaced and the surgery was completed uneventfully.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6227519
• Report Number: 2023826-2017-00026
• Device Sequence Number: 720933
• Product Code: MTA
• UDI-Device Identifier: 00841542103558
• UDI-Public: (01)00841542103558(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/07/2016

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: 02/28/2018
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK