MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for ORA SYSTEM 2000 8065998327 manufactured by Alcon Research, Llc - Irvine Technology Center.
[186537674]
The company clinical applications specialist (cas) reviewed the images and calculations. It was noted the surgeon was trying to give the patient a balance without compensating the patient? S near vision. The root cause of the reported event cannot be determined conclusively. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186537675]
A customer reported an unaccounted for miss with the toric intraocular lens in combination with the system's measurements. The patient had an unexpected outcome and reports blurry vision. The patient has been using contact lenses but reports no improvement with vision. The patient will undergo photorefractive keratectomy at a later date. Additional information received states the patient's eye is in line with the center of intraocular lens. The patient is only using the soft contact lenses to give a balance to see what works best for him without compensating the near vision. There are two related reports for this patient. This report addresses the patient's left eye, and another manufacturer report will be filed for the fellow eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00293 |
| MDR Report Key | 9897220 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-30 |
| 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 2000 |
| Generic Name | ABERROMETER, OPHTHALMIC |
| Product Code | NCF |
| Date Received | 2020-03-30 |
| Model Number | NA |
| Catalog Number | 8065998327 |
| Lot Number | ASKU |
| 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. Other | 2020-03-30 |