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

Model Number	MICL12.6
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	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the haptic of a 12.6mm micl12.6 implantable collamer lens, -10.5 diopter, was torn while being loaded and there was no patient contact.The back up lens was implanted.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid, in lens vial.Visual inspection found the haptic torn and pieces of the haptic missing.Work order search : no similar complaints were reported for units within the same lot.Claim # (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: 6296434
• Report Number: 2023826-2017-00207
• Device Sequence Number: 1031552
• Product Code: MTA
• UDI-Device Identifier: 00841542103039
• UDI-Public: (01)00841542103039(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/04/2017

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: No Information
• Device Expiration Date: 04/30/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/14/2017
• 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 (B)(4) - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL (B)(4) - LOT NUMBER UNK
• Patient Age: 18 YR