MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC IDESIGN RS; EXCIMER LASER SYSTEM

Model Number G301

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

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Section a2 : the accurate age wasn't provided but the patient's age is 40 years old and older.Device evaluation: a field service engineer (fse) visited site to service the system and found no issues in relationship to the overcorrection.The system is performing to specification.An application support manager (asm) also visited site and reported that the overcorrection was a result of doctor's training.Asm provided additional training and recommendations to avoid getting overcorrections.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

It was reported that patient was overcorrected with no more than 1 diopter and an enhancement was performed.No loss of best corrected visual acuity (bcva) and no patient injury was reported.No additional information was provided.

Manufacturer Narrative

Correction: h4: in initial report, the manufacturer date provided was inadvertently reported as july 1, 2021, however the correct date is july 24, 2021.Additional information: manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Manufacturer Narrative

Additional information: application support manager (asm) spoke with doctor regarding the procedures in which enhancements were performed.Doctor reported that all but one were bilateral enhancements.He was not able to provide the dates or patient demographics.No additional information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: IDESIGN RS
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18457379
• MDR Text Key: 332262419
• Report Number: 3012236936-2024-00053
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G301
• Device Catalogue Number: 0110-3450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2021
• 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