MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-12 for IOLMASTER 700 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[79885753]
Patient Sequence No: 1, Text Type: N, H10
[79885754]
The healthcare professional (hcp) reported the following: the post-refractive outcome after a cataract surgery with an intraocular lens (iol) implantation differed +15. 5 diopters from the target refraction. The hcp informed that an iol exchange is planned. The iol master was used for the original biometry measurements and iol calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00013 |
| MDR Report Key | 6709025 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-12 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-06-14 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2017-07-12 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| 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 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-07-12 |
| Returned To Mfg | 2017-06-27 |
| Model Number | NA |
| Catalog Number | 000000-1932-169 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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. Required No Informationntervention | 2017-07-12 |