N
Patient 1
(B)(4). 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).
MAUDE MDR 9622392
- MDR report key
- 9622392
- Report number
- 2028159-2020-00039
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-18
- Date received
- 2020-01-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. JASON MICHAELIDES
- Address
- 6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
- Phone
- 817-817-8175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LENSX LASER SYSTEM | OPHTHALMIC FEMTOSECOND LASER | ALCON LENSX, INC. | OOE | 550 | 8065998162 | NA | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
A SITE CLINICAL APPLICATION SPECIALIST REPORTED A TEN DEGREE TAG IN THE CAPSULE FOLLOWING THE LASER PORTION OF LASER ASSISTED CATARACT SURGERY WHICH WAS OTHERWISE COMPLETED WITHOUT ISSUE. DURING THE PHACO PORTION A POSTERIOR CAPSULE TEAR OCCURRED AND A VITRECTOMY WAS REQUIRED. THE LENS WAS SUCCESSFULLY REMOVED AND A SULCUS FIXATED INTRAOCULAR LENS WAS IMPLANTED. THE SURGEON INDICATES THE TAG THAT OCCURRED ON THE CAPSULE IS WHAT CAUSED THE CAPSULE TEAR. THE EVENT IS REPORTED AS RESOLVED.