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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection found the lens with no visible damage.The lens was returned in liquid.(b)(4).
Event or Problem Description
The reporter stated that a micl13.2 implantable collamer lens, -13.5 diopter, tore during loading.There was no patient contact.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.N.
Additional Manufacturer Narrative
Work order search: two similar claims were reported for units within the same lot.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6344330
• Report Number: 2023826-2017-00249
• Device Sequence Number: 16155058
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: (01)00841542103367(17)170630
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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: 06/30/2017
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 02/23/2017
• 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 AND LOT# - UNK; INJECTOR MODEL AND LOT # - UNK