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

Model Number	MICL13.2
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer? no.Lens not returned.(b)(4).
Event or Problem Description
The reporter stated the surgeon noticed debris on a 13.2mm micl13.2 implantable collamer lens, -13.0 diopter, during loading process.There was no patient injury and the backup lens was implanted.Additional information has been requested but none has been forthcoming.If additional contact or information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in vial in liquid.(b)(4).
Additional Manufacturer Narrative
Based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue."there was no patient contact.No additional information was provided." (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: 5755949
• Report Number: 2023826-2016-00869
• Device Sequence Number: 10618
• Product Code: MTA
• UDI-Device Identifier: 00841542103350
• UDI-Public: (01)00841542103350(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 06/13/2016

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: 11/30/2017
• 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: 06/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 07/22/2016; 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: UNK - LOT NUMBER: UNK