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 2016-06-07 for IOLMASTER 500 000000-1692-983 manufactured by Carl Zeiss Meditec Ag (jena).
[46762498]
The service inspection of the device and the evaluation of the patient printouts did not show any finding, which would have indicated a malfunction. The manufacturer reviewed further the log files from the instrument. The manufacturer subsequently discovered that under a specific circumstance, the initial intra-ocular lens calculation for the left eye could lead to an incorrect lens power value recommendation. The lens power calculations for the right eye are not affected. The calculation issue happens only when the keratometry value of left eye is out of the permissible range of 26d (diopter) to 80d of the iolmaster 500. In this case, the operator is instructed to manually enter the keratometry values. If the healthcare professional does not follow exactly the instructions of the practical operation guide (1692-983_addga01_us_151110), the calculation can lead to the error. The software deficiency only happens during the first time calculation. Any further calculation after restarting the iol calculation dialogue will deliver correct results for the iol power.
Patient Sequence No: 1, Text Type: N, H10
[46762501]
The healthcare professional (hcp) reported that the results of two intra-ocular lens (iol) power calculations performed for one patient's left eye were different. The recommended lens power values were all negative the first day and when re-doing the calculation the following day, the lens power values had the same magnitude as the prior day, but were all positive. The operator had entered manually the keratometry values for patient's right and left eye. This a normal process for patients, who have an irregular cornea like this patient with having a post pkp/corneal transplant. The iolmaster 500 was used for both iol calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2016-00006 |
| MDR Report Key | 5705305 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-07 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-05-09 |
| Date Added to Maude | 2016-06-07 |
| 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. 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, THURINGIA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 500 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2016-06-07 |
| Model Number | NA |
| Catalog Number | 000000-1692-983 |
| 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, THURINGIA 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-07 |