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 2020-02-03 for IOLMASTER 500 700 000000-1692-983 manufactured by Carl Zeiss Meditec Ag (jena).
[178134205]
The hcp was selecting a lens on pattern recognition (top left box of printout sheet) rather than reading the information within the box. Due to a (probably unintended) change of the drop-down list of iols, the sequence of iols on the printout sheet changed. In some cases, the change had been noticed and a different box (not the top left) was highlighted by the physician for lens selection, however in some cases it was not. This resulted in some patients being implanted not with the ideal iol.
Patient Sequence No: 1, Text Type: N, H10
[178134207]
A health care professional (hcp) reported that there had been four patients with incorrect surgical results after using the iolmaster 500 for the biometry measurements and lens power calculations. The hcp reported that one patient required additional medical intervention to correct impaired vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2020-00003 |
| MDR Report Key | 9662729 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2011-08-12 |
| Date Added to Maude | 2020-02-03 |
| 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. VERNON BROWN |
| 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, 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 500 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2020-02-03 |
| Model Number | 700 |
| Catalog Number | 000000-1692-983 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, 7745 GM 7745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-03 |