MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-28 for LENSAR LASER SYSTEM-FS 3D N/A 70-00005-001 manufactured by Lensar, Inc.
[181472280]
A review of the surgical files indicated the following: patient id (b)(6) - there was an opacity on the cornea, which likely interrupted the laser shots to the capsulotomy. There was patient movement observed during the surgical procedure because the pid arm was not locked properly. This would result in a partially incomplete capsulotomy, which could lead to the tear. No vitrectomy was performed patient id (b)(6) - the surgeon believed the small pupil contributed to the tear. Vitrectomy was performed there was no indication that the laser caused the reported events.
Patient Sequence No: 1, Text Type: N, H10
[181472281]
On 01/30/2020, cas reported that on (b)(6) 2020, the doctor reported two incidents of a radial tear. For patient id (b)(6), it was noticed during hydro dissection. No vitrectomy needed, able to proceed with planned iol. For patient id (b)(6), the surgeon believed to be caused by a smaller cap size due to small pupil. The tear was at the intellil nub, performed anterior vitrectomy, and switched from a toric iol to standard. Both instances occurred on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009026057-2020-00001 |
| MDR Report Key | 9771548 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2020-02-28 |
| 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. KEITH PECK |
| Manufacturer Street | 2800 DISCOVERY DRIVE STE. 100 |
| Manufacturer City | ORLANDO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 5756412 |
| Manufacturer G1 | LENSAR, INC |
| Manufacturer Street | 2800 DISCOVERY DRIVE STE. 100 |
| Manufacturer City | ORLANDO, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LENSAR LASER SYSTEM-FS 3D |
| Generic Name | LENSAR LASER SYSTEM-FS 3D |
| Product Code | OOE |
| Date Received | 2020-02-28 |
| Model Number | N/A |
| Catalog Number | 70-00005-001 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LENSAR, INC |
| Manufacturer Address | 2800 DISCOVERY DRIVE STE.100 ORLANDO, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |