MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2020-03-23 for MULTIFOCAL IOLS manufactured by Johnson & Johnson Surgical Vision, Inc..
[188489187]
Age/date of birth: unknown/ not provided. Brand name : unknown, as device is included in a masked study. Model number: unknown, as the serial number was not provided. Expiration date: unknown, as the serial number was not provided. Serial number: unknown, information not provided. Udi number: unknown, as the serial number was not provided. Catalog number: unknown, as the serial number was not provided. If explanted, give date: unknown, as device remains implanted. Initial reporter phone number, facility name, address: unknown as event is a clinical masked study. Pma/510(k) #: unknown, as the model number was not provided. Device manufacture date: unknown, as the serial number was not provided. The device is not returning for evaluation as it remains implanted; and since event is included in a clinical masked study, no product identifiers are provided, no investigation can be performed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188489188]
It was reported that a clinical masked study patient was implanted bilateral multifocal intraocular lenses (iols). It was learned that at 6th month visit, patient still has halos, is moderately bothered - extra caution driving at night. But there are no plans for surgical intervention. Pre-op best corrected distance visual acuity (bcdva) was 20/200 right eye (od) and 20/80 left eye (os). Bcdva for both eyes(ou) at the 6-month visit is 20/12. 5. No other information was provided. This mdr report pertains to the right eye (od). A separate report will be submitted for the left eye (os).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614546-2020-00139 |
| MDR Report Key | 9864312 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-11-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-23 |
| 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 | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | VAN SWIETENLAAN 5 |
| Manufacturer City | GRONINGEN 9728NX |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9728 NX |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | MFK |
| Date Received | 2020-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-23 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |