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 2018-07-18 for IOLMASTER 700 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[114405747]
This mdr is to report allegation of incorrect hyperopic surgical outcome of an additional patient, for the device issue reported under mdr 9615030-2017-00025 and 9615030-2017-00026. Retreatment of the patient was necessary due to the incorrect surgical outcome.
Patient Sequence No: 1, Text Type: N, H10
[114405748]
A health care professional (hcp) reported that a patient had an incorrect hyperopic surgical result after using the iolmaster 700 for biometry measurements and lens power calculations. The hcp reported that the patient will have lasik surgery to correct his/her vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00004 |
| MDR Report Key | 7700940 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-18 |
| Date of Report | 2018-06-19 |
| Date Mfgr Received | 2018-06-19 |
| Device Manufacturer Date | 2017-03-30 |
| Date Added to Maude | 2018-07-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSO |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THUERINGIA 7745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 7745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2018-07-18 |
| Model Number | NA |
| Catalog Number | 000000-1932-169 |
| 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 7745 GM 7745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-18 |