MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. IDESIGN AWS SYSTEM; REFRACTIVE MEASUREMENT

Model Number	0110-3450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.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.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for idesign system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that customer was unable to capture a patient with the idesign and wanted to make sure this was not a training issue.Clinical went through steps at trying to get a capture on this patient.The fiducials were not clear and were distorted and was only able to see 2 fiducials for the most part, at times a partial 3rd.Customer tried capturing with lights on and off, with artificial tears and without and had them gaze beyond the target with counting.Customer took over 30 scans and was able to get 2 scans, but both were outside of the approved treatment range with over 6 diopters of cylinder.This patient has been being followed since last year.The patient was originally almost a plano and was treated for mono vision.They attempted a conventional treatment with the star excimer and wanted to induce -2.25 diopters of sphere to make this eye for near vision.The patient now is unable to be refracted and went from having 20/20 vision in the right eye to 20/100.The original surgery date was in (b)(6) of 2019.Clinical explained to doctor that there was nothing further in assisting in capturing patient's eye.Doctor was hoping for some outside of the box capturing to get scans for this patient however, this is a special, off label circumstance and doctor agreed.Clinical let doctor know there was no deviation from the training message that would give him a better chance at capturing the patient.Since the two scans they were able to get were outside of the approved treatment range, we agreed it would be best to refer them back to medical affairs for further guidance.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10870279
• Report Number: 3006695864-2020-00502
• Device Sequence Number: 19557174
• Product Code: HKO
• UDI-Device Identifier: 05050474651432
• UDI-Public: (01)05050474651432
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K000327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0110-3450
• Device Catalogue Number: 0110-3450
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR