MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-26 for ORA SYSTEM WITH VERIFEYE MESSAGING 8065998330 manufactured by Alcon Research, Llc - Irvine Technology Center.
[181324690]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181324691]
A facility representative reported a patient that is planned to have an intraocular lens (iol) explant in the right eye. The patient has a hyperopic outcome and complains the right eye is still blurry. The facility reported the intra-operative aberrometer gave a false reading. Additional information received stated the iol has been explanted and replaced with a new lens. Symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2028159-2020-00146 |
MDR Report Key | 9756683 |
Report Source | OTHER |
Date Received | 2020-02-26 |
Date of Report | 2020-03-20 |
Date Mfgr Received | 2020-03-06 |
Device Manufacturer Date | 2016-03-09 |
Date Added to Maude | 2020-02-26 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. JONATHAN SCHLECH |
Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
Manufacturer City | FORT WORTH TX 76134 |
Manufacturer Country | US |
Manufacturer Postal | 76134 |
Manufacturer Phone | 8175514979 |
Manufacturer G1 | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
Manufacturer Street | 15800 ALTON PARKWAY |
Manufacturer City | IRVINE CA 92618 |
Manufacturer Country | US |
Manufacturer Postal Code | 92618 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ORA SYSTEM WITH VERIFEYE MESSAGING |
Generic Name | ABERROMETER, OPHTHALMIC |
Product Code | NCF |
Date Received | 2020-02-26 |
Model Number | NA |
Catalog Number | 8065998330 |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-02-26 |