MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-23 for HOYA ISERT 250 HOYA ISERT 250 (+20.00 D) manufactured by Hoya Surgical Optics, Inc..
[188819612]
This initial emdr is being submitted to fda for outside us like products reporting. Manufacturer's code for patient and device have been entered in this report. Manufacturer's codes for method, results and conclusion are pending for device return and product investigation. Once the investigation is completed, an follow-up report will be submitted to fda which will include the manufacturer's codes for method, results and conclusion.
Patient Sequence No: 1, Text Type: N, H10
[188819613]
Edge of leading iol haptic seems to be sharp/irregular and has cut the inferior equator of the lens capsule during aspiration of viscoelastic at the end of the cataract surgery procedure. Iol appeared to be centred at conclusion of cataract surgery but review 1 week later shows the intraocular lens has decentered inferiorly, causing monocular diplopia and blurred vision. Explanation to patient and family that the intraocular lens implant has decentered inferiorly and needs to be exchanged. Manufacturer informed. Intraocular lens removal, anterior vitrectomy and sulcus intraocular lens implanted (b)(6) 2020. Procedure went smoothly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006723646-2020-00002 |
| MDR Report Key | 9866575 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-03-31 |
| 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 | MR. GOUTHAM PENDYALA |
| Manufacturer Street | 15335 FAIRFIELD RANCH RD. SUITE 250 |
| Manufacturer City | CHINO HILLS, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 3896317 |
| Manufacturer G1 | HOYA CORPORATION |
| Manufacturer Street | 6-10-1 NISHI-SHINJUKU SHINJUKU-KU |
| Manufacturer City | TOKYO, 160-0023 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 160-0023 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYA ISERT 250 |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HQL |
| Date Received | 2020-03-23 |
| Model Number | HOYA ISERT 250 (+20.00 D) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA SURGICAL OPTICS, INC. |
| Manufacturer Address | 15335 FAIRFIELD RANCH RD. SUITE 250 CHINO HILLS, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |