MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADAPTAO INTRAOCULAR LENS

Model Number ADAPTAO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Loss of Vision (2139)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

The lens is not available for return.A device history record (dhr) review was performed and did not find any nonconformities or anomalies related to this complaint.Furthermore, there were no alerts, nonconformities, or excursions for bioburden, endotoxin, or sterilization testing.No excursions were found in microbial testing of the respective manufacturing area.Based on the available information, a root cause of the reported event could not be determined.

Event Description

It was reported that a patient started having tearing and pain in the left eye one day post-cataract surgery.Two days post-surgery, the patient exhibited anterior chamber inflammation and was given intravitreal antibiotic that same day as treatment.The diminished vision was observed by the patient on the 3rd day after surgery, and the best-corrected visual acuity (bcva) decreased to 2/60.A pars plana vitrectomy (ppv) was then performed and intravitreal antibiotic was administered to the patient.During the next follow-up, a decrease in the inflammation was noted.A vitreous biopsy was collected during the ppv and sent for culture; no organism growth was noted and gram stain and koh were negative.The patient is reported to have suffered endophthalmitis.The surgeon suspects the i/v fluids as the possible cause.As of the latest update, the patient is currently still under treatment at the facility.

• Brand Name: AKREOS ADAPTAO INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd; clearwater FL 33759
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 8786681
• MDR Text Key: 150893725
• Report Number: 0001313525-2019-00110
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P060022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: ADAPTAO
• Device Catalogue Number: ADAPTAOP1900
• Device Lot Number: 1747216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR