MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-08 for SYNERGEYES HDS HYBRID CONTACT LENSES CK45M-0900 NA manufactured by Synergeyes, Inc..
[4086401]
On (b)(6) 2013, synergeyes received a complaint from the od stating that the patient had to go to the emergency room in order to have his contact lens removed. The patient was fitted with synergeyes lens: ck45m-0900 and on (b)(6) the lens was shipped to (b)(4) eye care center. The patient did not immediately pick up his lens, instead the patient picked up the lens in (b)(6) 2013 without seeing the od for dispensing (verify fit, instructions for insertion/removal, and care instructions) for the lens. In (b)(6) 2013 (date cannot be confirmed), the patient still had not yet been to the od for dispensing. The patient had trouble removing the lens and went to the emergency room on his own accord to have the lens removed. The emergency room physician was able to remove the lens. The patient was seen by the od on the following days: (b)(6): the od determined that the patient had scratched his cornea and sought treatment to relieve the pain. The patient was prescribed vigamox and tobradex; (b)(6): the patient was still in pain and photophobic. The patient's visual acuity improved; (b)(6): patient described his pain as throbbing and at a level 9. The patient was prescribed ciloxan eye drops. However, the patient did not pick up the medicine as he could not afford the drug; (b)(6): the patient's visual acuity was improving; (b)(6): patient was prescribed loramox. The patient stated that he still had not picked up the ciloxan drops; (b)(6): the patient stated that he felt better.
Patient Sequence No: 1, Text Type: D, B5
[11256205]
The lens was measured for base curve and power. The results demonstrate that the lens met the labeled parameters. Results of the surface inspection determined that there were no defects on the lens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2013-00010 |
| MDR Report Key | 3481212 |
| Report Source | 05 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-10-14 |
| Date Mfgr Received | 2013-10-25 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-11-22 |
| 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, DIRECTOR |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604449636 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES HDS HYBRID CONTACT LENSES |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2013-11-08 |
| Returned To Mfg | 2013-10-25 |
| Model Number | CK45M-0900 |
| Catalog Number | NA |
| Lot Number | 049513 |
| ID Number | NA |
| Device Expiration Date | 2018-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-11-08 |