MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-10-14 for UNK-SOFT CONTACT LENSES manufactured by .
[57551165]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57551166]
On 23sep2016 our affiliate in (b)(4) received an email from an eye care provider who reported that? In past times there was a patient (pt) who had a 1-day type cl user (product name unknown) who was on the verge of corneal transplantation (affected eye unknown) in the past time.? No additional details were received. A call was placed to the ecp and a medical interview was scheduled for (b)(6) 2016. On (b)(6) 2016 during the medical interview the additional information was obtained from the ecp as follows: the ecp reported that? He/she reported this case back to us in 2010.? The affiliate advised the ecp that no information can be found to reference this event as being previously reported. The ecp reported that he/she will contact the hospital where he/she worked at that time and see if the pts medical record is available. The ecp refused to provide any additional medical information. The product, lot number, and product availability are unknown. The event date is also unknown. This event is being reported as a worst case event. If additional information is received it will be reported within 30 days of receipt. Serious reportable event trends are reviewed quarterly in franchise management review meetings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1033553-2016-00122 |
| MDR Report Key | 6031312 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-10-14 |
| Date of Report | 2016-09-23 |
| Date Mfgr Received | 2016-09-23 |
| Date Added to Maude | 2016-10-14 |
| 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 | ROSE HARRELL |
| Manufacturer Street | 7500 CENTURION PARKWAY |
| Manufacturer City | JACKSONVILLE FL 32256 |
| Manufacturer Country | US |
| Manufacturer Postal | 32256 |
| Manufacturer Phone | 9044433364 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK-SOFT CONTACT LENSES |
| Generic Name | UNK-SOFT CONTACT LENSES |
| Product Code | HPX |
| Date Received | 2016-10-14 |
| Model Number | NA |
| Catalog Number | UNK-SOFT CONTACT LENSES |
| Lot Number | UNK-UNK-SOFT CONTACT LENSES |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-10-14 |