MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-02 for SYNERGEYES MULTIFOCAL HYBRID CONTACT LENS SM73F-0175+STDSM NA manufactured by Synergeyes, Inc..
[3597471]
On (b)(6) 2013 synergeyes rec'd a complaint where in after wearing synergeyes lenses for approximately 6 months the pt developed an ulcer on each eye. The practitioner's office staff member stated that the practitioner instructed the pt to use sustain artificial tears (otc product). The practitioner's follow-up call to the pt on (b)(6) 2013 determined that the pt's ulcers had healed, although this was not physically verified by the practitioner.
Patient Sequence No: 1, Text Type: D, B5
[10951361]
This event is related to the following add'l device: model number sm73f-0125+stdlg; lot number 047549; expiration date 10/2017. Manufacture date 11/2012. The lenses were not returned to synergyeyes, inc as the pt disposed of the lenses.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2013-00003 |
| MDR Report Key | 3236034 |
| Report Source | 05 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-07-01 |
| Date of Event | 2013-04-12 |
| Date Mfgr Received | 2013-06-20 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2013-07-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KINCADE, QA MGR |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604443696 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES MULTIFOCAL HYBRID CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | OBO |
| Date Received | 2013-07-02 |
| Model Number | SM73F-0175+STDSM |
| Catalog Number | NA |
| Lot Number | 047609 |
| ID Number | NA |
| Device Expiration Date | 2017-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGEYES, INC. |
| Manufacturer Address | CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-02 |