MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-01-24 for AMO TAC VITRECTOMY HANDPIECE OM0201011D manufactured by Abbott Medical Optics.
[4036445]
It was reported that during iol implantation the surgeon created a rent in the posterior chamber and vitrectomy cutter failed to operate. Customer stopped the surgery and shifted the patient to a different hospital location where the implanted single piece abbott medical optics iol was explanted and replaced with a new three piece sensar iol. Additional information was received concerning the patient condition stating that there was "anterior chamber reaction 2+ to 3+" and that there is a blood clot. The iol is centered at the sulcus. Although requested, the patient gender and date of birth was not provided. The date of implant, date of explant, and date of event(s) were not provided. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[11423793]
All pertinent information available to abbott medical optics has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[11899108]
The amo tac vitrectomy handpiece was evaluated and it was determined the motor/gearbox failed. The tac handpiece motor failure can be the result of several issues, including age. The scrub nurse is required to prime and test the handpiece prior to surgery as per directions for use. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[18430608]
Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[19210285]
It was reported second procedure: post vitrectomy the incision was enlarged to explant the single piece sensar iol in a secondary procedure. After anterior vitrectomy a 3-piece sensar was placed in the sulcus. Incision was sutured with single 10-0 vicryl suture. On post operative day 1: intraocular pressure (iop) was 24 mm of hg but 2nd day onwards iop was high 40 mmhg and on the day of 2nd operative procedure it was 44 mmhg - so pre operatively mannitol was given. Corneal edema developed on 3rd post treatment day because of high intraocular pressure. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[20498321]
The manufacturer report number should have been 3006695864. All pertinent information available to abbott medical optics at this time has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020664-2014-00005 |
| MDR Report Key | 3591864 |
| Report Source | 00,05 |
| Date Received | 2014-01-24 |
| Date of Report | 2013-12-26 |
| Date Mfgr Received | 2014-07-21 |
| Device Manufacturer Date | 2011-05-24 |
| Date Added to Maude | 2014-01-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | 1246 REDWOOD BLVD |
| Manufacturer City | REDDING CA 96003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 96003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMO TAC VITRECTOMY HANDPIECE |
| Generic Name | PHACO ACCESSORY |
| Product Code | MLZ |
| Date Received | 2014-01-24 |
| Model Number | OM0201011D |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-24 |