MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-05 for LENSX LASER SYSTEM 550 8065998162 manufactured by Alcon Lensx, Inc..
[177940233]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177940234]
An eyecare professional reported black holes during flap creation. Parts of the interface of the flap were not lasered. Error was not recognizable on the machine. Procedure was completed. Extended healing process was caused by massive manipulation to lift the flap. New information was received. No error message was recognizable on the machine. There are multiple related reports for this facility. This report addresses the patient on (b)(6) 2019 left eye and other manufacturer reports will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00067 |
| MDR Report Key | 9674540 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2014-03-31 |
| Date Added to Maude | 2020-02-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| Manufacturer G1 | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY SUITE #175 |
| 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 | LENSX LASER SYSTEM |
| Generic Name | OPHTHALMIC FEMTOSECOND LASER |
| Product Code | OOE |
| Date Received | 2020-02-05 |
| Model Number | 550 |
| Catalog Number | 8065998162 |
| 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 LENSX, INC. |
| Manufacturer Address | 33 JOURNEY SUITE #175 ALISO VIEJO CA 92658 US 92658 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-05 |