MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-10-28 for VISUMAX LASER KERATOME 000000-2177-848 manufactured by Carl Zeiss Meditec Ag (jena).
[125276753]
The doctor reported that the residual stromal tissue in both eyes were not detected and extracted because the patient's eye buttons appeared circular when laid out after removal; however, the procedure is to spread out the lenticule after removal on top of the cornea in order to check for complete removal.
Patient Sequence No: 1, Text Type: N, H10
[125276754]
On (b)(6) 2018, three months after performing a refractive surgery a health care professional (hcp) reported that a patient was complaining of poor visual acuity. It was reported that on (b)(6) 2018, the hcp dilated the patient, and he observed a small crescent shaped lenticule fragment in the superior nasal portion of the right eye. It was further reported that on (b)(6) 2018 the lenticule fragment was removed from the patient's right eye by the hcp. The hcp reported that the patient's left eye will be revisited. No further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00009 |
| MDR Report Key | 8011159 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-10-28 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-09-26 |
| Device Manufacturer Date | 2016-11-03 |
| Date Added to Maude | 2018-10-28 |
| 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 | MR. VERNON BROWN |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THUERINGIA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISUMAX LASER KERATOME |
| Generic Name | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
| Product Code | OTL |
| Date Received | 2018-10-28 |
| Model Number | NA |
| Catalog Number | 000000-2177-848 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THUERINGIA 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-28 |