MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-05 for ORA SYSTEM WITH VERIFEYE MESSAGING 8065998330 manufactured by Alcon Research, Llc - Irvine Technology Center.
[182285966]
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
[182285967]
A physician reported during aberrometer assisted cataract surgery, red reflected light flooded numerous regions in the microscope field of view which caused the surgeon to mistake the depth of the instruments in the patient's eye causing an injury requiring an anterior vitrectomy. The surgeon was able to complete the surgery with the planned intraocular lens. The patient is doing well post operatively. Additional information received confirmed a capsular tear occurred requiring an anterior vitrectomy due to the red glare that was being caused by the aberrometer. The doctor mistook the glare as a red reflux from the microscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00206 |
| MDR Report Key | 9795413 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Model Number | NA |
| Catalog Number | 8065998330 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-05 |