MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	AQ2010V
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).Visual inspection of the lens found a piece of optic and haptic torn off and there was evidence of dry clear and red residue on the optic surface.The lens was returned dry in case.There was no visible damage to the cartridge.(b)(4).
Event or Problem Description
The reporter stated the surgeon was inserting an aq2010v three-piece silicone lens, +23.0 diopter, and noted the lens was torn.There was a patient contact with the cartridge but not with the lens.There was no patient injury and the backup lens was implanted.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5736193
• Report Number: 2023826-2016-00827
• Device Sequence Number: 16265805
• Product Code: HQL
• UDI-Device Identifier: 00841542100281
• UDI-Public: (01)00841542100281(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P900048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2016

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: 10/31/2018
• Device Model Number: AQ2010V
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2016
• Supplement Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1