MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-27 for LENSX LASER SYSTEM 550 8065998162 manufactured by Alcon Research, Llc - Irvine Technology Center.
[182177761]
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
[182177762]
A customer reported an anterior capsular bag rupture during a laser assisted cataract procedure. The optical coherence tomography (oct) mirror inside the laser arm did not move properly so the oct plans were incorrect. The capsulorhexis was performed on the cortex of the crystalline lens. After laser portion, objective was moved manually in order to unlock the oct mirror connected to the objective. The capsulotomy and lens fragmentation were completed with the laser. In the operating room, the surgeon realized that the capsulotomy was performed on the cortex instead of the anterior capsule. Lens fragmentation was noted to have been performed inside the crystalline. An intraocular lens was not implanted because an anterior capsular bag rupture occurred. The rupture was caused manually by the surgeon when searching the anterior capsule that was supposed to be already cut from the capsulotomy performed by the laser. The doctor decided to check the patient the following day in order to decide further treatment plan. The field service engineer explained that the oct reference arm mirror assembly inside the gantry was blocked. At the moment of surgery, no one realized that the oct image was not positioned correctly regarding the depth of treatment. No error messages or warning alarms appeared on the laser. Additional information was received. The patient? S eye is stable and quiet. The doctor decided to wait a couple of months and, then will perform a secondary implant on this patient's right eye with a monofocal intraocular lens (iol) in the sulcus or an iris fixation. The patient's left eye will be done in the future with best iol choice possible. The patient's refraction now is really bad so the patient is very unhappy, angry and disappointed. The patient will be managed in the mean time with a contact lens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00043 |
| MDR Report Key | 9631361 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-27 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2015-04-21 |
| Date Added to Maude | 2020-01-27 |
| 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. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| Manufacturer G1 | ALCON RESEARCH, LLC - 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 | LENSX LASER SYSTEM |
| Generic Name | OPHTHALMIC FEMTOSECOND LASER |
| Product Code | OOE |
| Date Received | 2020-01-27 |
| Model Number | 550 |
| Catalog Number | 8065998162 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-27 |