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	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated a 12.6mm micl12.6 implantable collamer lens, -16.0 diopter, tore during loading.There was no patient injury and the backup lens was used.
Additional Manufacturer Narrative
Additional information received - the reporter indicated the lens was inserted and was noted to be torn after insertion.The lens was removed with no patient injury and replaced with another same model/diopter lens.The post-op bscva was 20/30-1, with photophobia.Results: visual inspection of the returned product found pieces of lens optic and haptics torn off and missing.The lens was returned dry and there was evidence of reddish color residue on the lens surface.Conclusions: based on the complaint history, work order search, medical review and product evaluation, a specific root cause of the event could not be determined.(b)(4).
Additional Manufacturer Narrative
(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: 6140275
• Report Number: 2023826-2016-01709
• Device Sequence Number: 16340356
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: (01)00841542103145(17)170531
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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: 05/31/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 01/19/2017; 02/03/2017
• 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 SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Patient Age: 66 YR
• Patient Weight: 136