MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE PRO; UNIT, PHACOFRAGMENTATION

Model Number NGP680301

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Edema (1791); Visual Impairment (2138); Eye Burn (2523)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Acknowledgement 2 for this report was received on march 18, 2022.There was a delay in receiving acknowledgement 3.This report was resubmitted on march 21, 2022 due to failed acknowledgement 3 that was received on sunday, march 20, 2022.The failure was attributed to the electronic processing of the emdr by fda due to exceeding the number of characters for city: state, province, or territory.(b)(6).Patient identifier, age, weight, ethnicity: information not available/not provided.(b)(6).Device evaluation: the field service engineer performed a system check and the system passed all de tests, not problem found, not possible to reproduce the issue.Based on the field engineers report a product quality deficiency or product malfunction could not be determined.Manufacturing record evaluation: the manufacturing records for the laser system were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It has been reported that the surgeon had a result of corneal edema in the main incision in one of his surgeries.The surgeon did not specify whether the patient had previous problems, if he made an excessive use of ultrasounds, etc.He has had no problems in the other surgeries.The issue was noticed after application.Through follow-up it was learnt that daily monitoring of the patient with preventive occlusion is being performed; fortified eye drops plus therapeutic lens have been used; the edema lasted for three weeks in the patient's eye; and fairly transparent cornea, high residual astigmatism.Patient information cannot be provided due to personal data privacy legislation/policy.No further information has been provided.

Manufacturer Narrative

Corrected data: after follow-up done, it was confirmed that the health effect - clinical code (2523) - eye burn is not applicable in section 'h6' of the initial mdr report for the reported corneal burn as it was confirmed to be a corneal edema.The information has been corrected in this supplemental mdr report and the following field was updated accordingly: all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE PRO
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13853838
• MDR Text Key: 293093063
• Report Number: 3012236936-2022-00629
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K151636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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