MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2012-09-06 for BALANCED SALT SOLUTION ENDOSOL manufactured by Abbott Medical Optics.
[2995604]
It was reported that the doctor performed a vitrectomy procedure on (b)(64) 2012, using endosol, balanced salt solution. It was stated that the patient presented with swelling and toxic syndrome on the anterior segment of the eye. It was reported by the doctor that endosol was involved, although the doctor did not think that the endosol is the reason for the adverse event. The patient was treated medically and reportedly recovered. Initially, the doctor reported to abbott medical optics (amo) that the patient was ok; however, it was later reported that the patient had a ''loss of vision and a long recovery process with serious risk involved. ' no further information was available at the time of submitting the medical device report.
Patient Sequence No: 1, Text Type: D, B5
[10130805]
(b)(6). (b)(4). Prior to release to market, the endosol met all manufacturing specifications. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[10146853]
Evaluation of the returned samples of amo endosol demonstrates that the product met specifications and release requirements. (b)(4) - the manufacturing record review indicated that the batch passed all acceptance criteria for all tests performed and was within specifications. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[18170318]
Corrected data: (b)(6) 2012. All pertinent information available to the manufacturer has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614546-2012-00157 |
| MDR Report Key | 2731611 |
| Report Source | 01,05,06,07 |
| Date Received | 2012-09-06 |
| Date of Report | 2012-08-10 |
| Date of Event | 2012-08-09 |
| Date Mfgr Received | 2012-10-05 |
| Device Manufacturer Date | 2012-03-12 |
| Date Added to Maude | 2012-09-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. STEPHANIE SOLOMON |
| Manufacturer Street | ABBOTT MEDICAL OPTICS INC. 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7145663731 |
| Manufacturer G1 | . |
| Manufacturer Street | AMO GRONINGEN B.V. P.O. BOX 901 |
| Manufacturer City | GRONINGEN 9700AX |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9700 AX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALANCED SALT SOLUTION |
| Generic Name | SURGICAL ADJUNCTS |
| Product Code | KIP |
| Date Received | 2012-09-06 |
| Returned To Mfg | 2012-09-20 |
| Model Number | ENDOSOL |
| Catalog Number | ENDOSOL |
| Lot Number | 12C1203 |
| Device Expiration Date | 2014-02-28 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-09-06 |