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 2020-03-26 for SENSAR AR40E AR40E00215 manufactured by Johnson & Johnson Surgical Vision, Inc..
[187045080]
(b)(4). Device evaluation: product testing could not be performed because the product was not returned as it was discarded. The reported complaint was not confirmed. Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported. The search revealed that no other complaint folder has been created for this production order number. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[187045081]
It was reported that monofocal intraocular lens (model ar40e +21. 5 diopter) was explanted from patient? S operative eye in secondary surgical procedure because of patient experiencing dislocation of the lens. On (b)(6) 2019 the lens was reportedly repositioned. Pars plana vitrectomy was performed during explant procedure. In addition, intrascleral fixation and iris repair was performed. Lens from another manufacturer was used as the replacement lens for the patient. No incision enlargement and no patient injury reported. Patient is happy with the vision. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2020-00290 |
| MDR Report Key | 9886100 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-26 |
| 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 | ROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSAR |
| Generic Name | MONOFOCAL IOLS |
| Product Code | HQL |
| Date Received | 2020-03-26 |
| Model Number | AR40E |
| Catalog Number | AR40E00215 |
| Device Expiration Date | 2005-10-31 |
| 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 | 2020-03-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |