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

Model Number	AQ2010V
Medical Device Problem Codes	Bent (1059); Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diopter +20.00.Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).Evaluation method: lens work order search evaluation results: a lens work order search revealed there were no similar complaints within the work order.Visual inspection of the returned product found the lens optic torn.One loop haptic is bent and partially torn.There was evidence of dry clear surgical residue on optic surface.Conclusions: conclusion not yet available.Evaluation is in progress.(b)(4).
Event or Problem Description
The reporter stated the surgeon inserted an aq2010v +20.00 diopter three piece silicone lens.The haptic got damaged during insertion into the patient's left eye.The lens was removed and one suture was used.There was no patient injury.Cause of damaged haptic is unknown.Lens tore upon insertion into the patient's left eye.Lens was removed with no patient injury.Another same model and size lens was implanted.
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: 5443121
• Report Number: 2023826-2016-00135
• Device Sequence Number: 18902615
• Product Code: HQL
• UDI-Device Identifier: 00841542100229
• UDI-Public: (01)00841542100229(17)200229
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/29/2020
• Device Model Number: AQ2010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2016
• Supplement Report FDA Received Date: 05/03/2016
• 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 AND LOT NUMBER - UNK
• Patient Age: 70 YR