MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-07 for CRYSTALENS ACCOMMODATING IOL HD500 UNKNOWN CRYSTALENS IOL manufactured by Bausch + Lomb.
[183568616]
This case was documented in the article "z syndrome still possible with newer generation crystalens" by michelle dalton, eyeworld contributing editor. (ascrs eyeworld. Org, april, 2010) (source: steven g. Safran, m. D. ). Though requested, no additional information has been received for this case. The product lot number and serial number are unknown. The product is not available for evaluation. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[183568617]
Published article - case 2 of 2. Patient with intraocular lens (iol) implant presented post-yag with z syndrome; the temporal plate was buckled because of anterior insertion of the plate above the equator and fibrosis, leading to the superior part of the optic twisting forward and the inferior part pushing back. Additionally, the lens was tilted on the plane and tilted on the plane of the plates. Z syndrome with the iol was noticed from the angle of the slit beam. After plate dissection, partial capsulectomy, a capsular tension ring (ctr) was inserted in the bag over the plates using a? Fishtail? Technique. The lens optic was then pushed behind the posterior capsule and, finally, triamcinolone-assisted vitrectomy was performed. Initial refraction after the lens implantation was? 0. 25? 3. 0 x 30 degrees. After resolving the z syndrome, the patient? S refraction was? 0. 25 and had an uncorrected vision of 20/25 +2. Though requested, no additional information has been received for this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00030 |
| MDR Report Key | 9682081 |
| Report Source | LITERATURE |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-09 |
| Date of Event | 2010-04-01 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-07 |
| 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 | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246659 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYSTALENS ACCOMMODATING IOL |
| Generic Name | LENS, INTRAOCULAR, ACCOMMODATIVE |
| Product Code | NAA |
| Date Received | 2020-02-07 |
| Model Number | HD500 UNKNOWN CRYSTALENS IOL |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N. GOODMAN ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-07 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-07 |