MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC KERATOME, AC-POWERED; FEMTOSECOND LASER

Model Number 20003K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Perforation (1792)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, weight and ethnicity: unknown, not provided.(b)(6).Field service engineer serviced the system and reported that on z-calibration test, was found -37 for -25 z baseline, performing a flap of 159 m for 120 m of depth.Z-calibration baseline was corrected to -25 m and the flap depth measure was 144 m.Z- calibration baseline was corrected to -15 m and the measure flap depth was 128 m.System released for surgeries.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision has been submitted.

Event Description

It was reported that while positioning the ring segment, it made a perforation through the endothelium.No other information is available.

• Brand Name: KERATOME, AC-POWERED
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 11532523
• MDR Text Key: 241314162
• Report Number: 3006695864-2021-07368
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141852
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20003K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2006
• 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): Other