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

Model Number EPIPHANY

Device Problems Activation, Positioning or Separation Problem (2906); Torn Material (3024)

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

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter stated the epiphany injectors from lot #1306680 had been injecting the lenses sideways into the patients' eyes.There was no damage to the lenses.The lenses were implanted and remain implanted.The surgeon had to increase the wound size and insert the injector further into the eye to implant the lenses.There was no patient injury related to this event.The reporter indicated they felt the injectors from this lot may be defective.

Manufacturer Narrative

Incorrectly reported as product problem/malfunction; should be adverse event.Incorrectly reported as malfunction; should be serious injury.(b)(4).Additional information: conclusion - investigation concluded two probable causes: (1) end user familiar with the product, (2) lubricity of the product.Corrective actions shall be implemented as required.(b)(4).

Manufacturer Narrative

Inadvertently omitted to check box on previous submission: required intervention to prevent permanent impairment/damage (devices).(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; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5955109
• MDR Text Key: 54885336
• Report Number: 2023826-2016-01287
• Device Sequence Number: 1
• Product Code: MSS
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2017
• Device Model Number: EPIPHANY
• Device Catalogue Number: N/A
• Device Lot Number: 1306680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2014
• 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: LENS MODEL: UNK - SERIAL #: UNK
• Patient Outcome(s): Required Intervention