D
Patient 1
CONTRACTED AK ON LEFT EYE, ALMOST BLIND.
MAUDE MDR 6493201
- MDR report key
- 6493201
- Report number
- MW5069095
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-05-21
- Date received
- 2017-04-12
- Adverse event
- 0
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Related Records#
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-12 | 0 | 1. S |
Event Narratives#
Related GUDID Devices By Product Code#
Related PMN/PMA Records By Product Code#
| Type | Submission | Product code | Device | Applicant | Decision date |
|---|---|---|---|---|---|
| PMA | P860022S061 | MWL | Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) | Bausch & Lomb | 2025-12-16 |
| PMA | P860022S060 | MWL | Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl | Bausch & Lomb | 2024-07-18 |
| PMA | P990018S010 | MWL | ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti | Menicon Co, Ltd. | 2023-06-16 |
| PMA | P990018S007 | MWL | Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight | Menicon Co, Ltd. | 2022-11-16 |
| PMA | P870024S060 | MWL | FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid | CooperVision, Inc. | 2022-06-16 |
| 510(k) | K253822 | HQD | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026-03-27 |
| 510(k) | K242393 | HQD | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers, Inc. | 2024-11-01 |
| 510(k) | K241398 | HQD | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | 2024-10-22 |
| 510(k) | K241571 | HQD | BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight | 2024-08-14 |
| 510(k) | K240618 | HQD | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2024-04-03 |
| PMA | P880098S012 | HQD | MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | 2002-12-10 |
| PMA | P880098S011 | HQD | MENICON SF-P (TM) | Menicon Co, Ltd. | 2000-09-06 |
| PMA | P860022S052 | HQD | BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A) | Bausch & Lomb | 2000-02-04 |
| PMA | P860022S051 | HQD | ITAFLUOROFOCON A AND B | Bausch & Lomb | 1998-03-31 |
| PMA | P860022S050 | HQD | IPAFLUOROFOCON A AND B | Bausch & Lomb | 1998-03-31 |