MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-08-12 for INTREPID AUTOSERT IOL HANDPIECE 8065751755 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[22738598]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22738599]
A surgeon reported that the intraocular lens injector delivered the intraocular lens heavily, damaging the capsular bag. The surgeon repaired the capsule. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[31823449]
The clinical analyst reviewed the file and stated the following:? The customer reported the injector delivered the lens heavily into the bag. The capsule of the eye was damaged. The customer noted? The doctor solved immediately?. In the surgeon? S opinion it is unknown what caused or contributed to the event. However, the surgeon did indicate that the performance of the device did not cause or contribute to the event. No surgical intervention was required. The status of the patient was noted as resolved. Posterior capsule (pc) tear is a potential consequence of cataract extraction by phacoemulsification. Predisposition to pc tear or zonular dehiscence can be influenced by many factors including, but not limited to, congenital posterior lenticonus, posterior sub capsular (psc) cataract, poor visibility secondary to patients comorbidity [i. E. Dense arcus, pterygium, band keratopathy, corneal scars, interstitial keratitis], poor microscope illumination [red reflex], ergonomic obstacles, limited intraocular working space, abnormally long or short axial lengths, pseudoexfoliation, zonular laxity, poor dilation, intraoperative floppy iris syndrome (ifis), dense cataracts, asteroid hyalosis, or inadvertent patient movement. The conditions that increase the risk of pc tear during phacoemulsification include ergonomic obstacles, limited intraocular working space, poor visualization, increased nuclear size and density, weakened zonule, a radial tear in the capsulorhexis, and an inability to rotate the nucleus or epinucleus. These conditions may arise either because of the ocular anatomy, or because of surgical technique. There is no evidence contained within the reported information at this time that indicates that the design or performance of the injector had any effect on the integrity of the posterior capsule. The root cause of the reported event cannot be determined conclusively.? No further information was able to be obtained from this customer. With no additional, related information provided, the customers reported event was not able to be confirmed. Posterior capsule tear is an issue that is occasionally reported with cataract surgery. However, a review of the complaint trends shows that the frequency reported is within known levels for this event. A root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2015-07565 |
| MDR Report Key | 4996333 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-08-12 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-11-17 |
| Date Added to Maude | 2015-08-12 |
| 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. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTREPID AUTOSERT IOL HANDPIECE |
| Generic Name | APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED |
| Product Code | HQR |
| Date Received | 2015-08-12 |
| Model Number | NA |
| Catalog Number | 8065751755 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-12 |