MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-03-28 for WAVESCAN ADVANCED CUSTOMVUE 0070-1478 manufactured by Abbott Medical Optics.
[41304408]
Udi #: (b)(4). Event date: not provided. (b)(4). Applications support manager (asm) visited the account and checked the plastic from the day of that surgery and found it to be within specifications. Verified wavescan (b)(4) daily verification of calibration was also within specifications. Abbott representative reviewed the etiology and treatment of central islands with surgeon. All questions were answered and also reviewed different ways to take off the epithelium and post op regimens to avert and ameliorate central islands. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[41304409]
Account reported that they experienced central island from custom photorefractive keratectomy procedures on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2016-00297 |
| MDR Report Key | 5530437 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-28 |
| Date Mfgr Received | 2016-02-29 |
| Device Manufacturer Date | 2007-06-18 |
| Date Added to Maude | 2016-03-28 |
| 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 | MRS. VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVESCAN ADVANCED CUSTOMVUE |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2016-03-28 |
| Model Number | 0070-1478 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-28 |