MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS IFS; FEMTOSECOND LASER

Model Number J20007K

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient code of (b)(4) is provided for aborted procedure.The system was evaluated by a field service engineer.All modes of operation and calibrations were verified and no failures were detected.In addition, a preventative maintenance was performed.The unit complied with all factory settings.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The surgery center reported that a laser vision correction patient experienced an incomplete laser treatment and the procedure was aborted.A brief description from the surgery center indicated a 102-oscillator mode lock error during treatment.The procedure was aborted and procedure was not completed on the same visit/day.

• Brand Name: IFS
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 7631463
• MDR Text Key: 112134609
• Report Number: 3006695864-2018-01402
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474573475
• UDI-Public: (01)05050474573475
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: J20007K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention