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

Model Number	AQ2010V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	01/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diopter +05.00.Silicone ultraviolet-absorbing posterior chamber three piece foldable intraocular lens (elastimide®).(b)(4).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 torn in half.A piece of optic and one loop haptic torn off and missing.Lens was returned dry.There was evidence of dry clear surgical residue on optic surface.Off-label, unapproved or contraindicated use.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted an aq2010v +05.00 diopterthree piece silicone lens.The lens tore upon insertion into the patient's eye.The incision was enlarged to remove the lens and one suture was used to close the wound.At this time no lens was implanted, they did not have a backup lens.This lens was used as a piggyback lens.The reported was informed that using lens as a piggyback is considered off-label use.Two weeks later on (b)(6) 2016, a lens was implanted.
Additional Manufacturer Narrative
Based on the dhr review and root cause analysis, the probable cause could not be determined at this time.There were no documented issues and concerns with the manufacturing and inspection processes which may cause scratch on the lens.Physician report does not indicate that any exceptional event or condition would have caused the complaint issue.Per medical review: reportedly, haptic of a 3-pice silicone iol was torn off during insertion requiring intraoperative lens removal.Incision was enlarged and suture was placed.This lens was used as a piggyback lens and the surgery center didn`t have another one for replacement so, another lens was implanted two weeks later.No reported postoperative sequelae.Per dfu indications: "the silicone 3p iols are indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by extracapsular cataract extraction" and therefore, there is no sufficient safety and effectiveness data to support use of this lens as a piggyback iol.(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: 5414890
• Report Number: 2023826-2016-00118
• Device Sequence Number: 453721
• Product Code: HQL
• UDI-Device Identifier: 00841542101226
• UDI-Public: (01)00841542101226(17)190228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Followup
• Report Date (Section B): 01/06/2016

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: 02/28/2019
• Device Model Number: AQ2010V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2016
• Supplement Report FDA Received Date: 04/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1