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

Model Number	MICL13.2
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event problem and evaluation codes: results codes: visual inspection of the returned product found the lens stuck inside an sfc-45 fp cartridge.The cartridge tip was split and a foam tip plunger was stuck inside.There was evidence of dry surgical residue.Conclusions code: based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated a 13.2mm micl13.2 implantable collamer lens, -9.0 diopter, became stuck in the loader.There was no patient contact and the backup lens was used.

• 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: 6140268
• Report Number: 2023826-2016-01710
• Device Sequence Number: 1248291
• Product Code: MTA
• UDI-Device Identifier: 00841542103275
• UDI-Public: (01)00841542103275(17)180430
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2016

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: 04/30/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 12/01/2016
• 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 1330315; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Patient Age: 33 YR