MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EPIPHANY INJECTION SYSTEM; INTRAOCULAR LENS FOLDERS AND INJECTORS

Model Number	EPIPHANY
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber three-piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a cq2015a three-piece collamer lens, +21.5 diopter, in the patient's eye on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to lens tear contributed to a faulty epiphany injector.The reporter stated that two cases resulted in adverse events with enlarged incision and suture added.Reporter was unable to provide details on all cases.The surgeon implanted the backup lens.No additional information provided by reporter.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The surgeon stated that the cartridge tip looked sharp and believed this caused the lens tear.
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found lens torn in two pieces.Conclusion - investigation concluded two probable causes: end user familiar with the product, lubricity of the product.Corrective actions shall be implemented as required.Claim# (b)(4).
Additional Manufacturer Narrative
(b)(4).

• Brand Name: EPIPHANY INJECTION SYSTEM
• Common Device Name: INTRAOCULAR LENS FOLDERS AND INJECTORS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6097776
• Report Number: 2023826-2016-01545
• Device Sequence Number: 784289
• Product Code: MSS
• UDI-Device Identifier: 00841542102018
• UDI-Public: (01)00841542102018(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K090161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 08/01/2017
• Device Model Number: EPIPHANY
• Device Lot Number: 1312755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 12/05/2016; 04/27/2017; 05/05/2017
• 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: EPIPHANY INJECTION SYSTEM LOT# 1312755
• Outcome Attributed to Adverse Event: Required Intervention