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

Model Number EPIPHANY

Device Problem Torn Material (3024)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

Collamer® ultraviolet-absorbing posterior chamber three-piece foldable intraocular lens.(b)(4).

Event 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.

Manufacturer Narrative

(b)(4).

Event Description

The surgeon stated that the cartridge tip looked sharp and believed this caused the lens tear.

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).

Manufacturer Narrative

(b)(4).

• Brand Name: EPIPHANY INJECTION SYSTEM
• Type of Device: INTRAOCULAR LENS FOLDERS AND INJECTORS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; urayasu-shi; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6097776
• MDR Text Key: 59716696
• Report Number: 2023826-2016-01545
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00841542102018
• UDI-Public: (01)00841542102018(17)180531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EPIPHANY INJECTION SYSTEM LOT# 1312755
• Patient Outcome(s): Required Intervention