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

Model Number	MICL13.2
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lens not returned.
Event or Problem Description
The reporter stated that a 13.2mm micl13.2 lens, -12.00 diopter, tore during loading on (b)(6) 2016.There was no patient contact and a backup lens was used.The cause of the tear is unknown.
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in the lens vial.Visual inspection found the haptic torn with a piece missing.(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: 6074378
• Report Number: 2023826-2016-01570
• Device Sequence Number: 549681
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: (01)00841542103336(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/24/2016

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: 01/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 11/21/2016
• 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 UNK, LOT NUMBER UNK; INJECTOR MODEL UNK, LOT NUMBER UNK
• Patient Age: 24 YR