Doctors at Key-Whitman Eye Center and other cataract practices using the
PRG Dallas Surgery Center are working on an important issue. Some post-operative
cataract patients who had surgery here at the PRG Dallas Surgery Center
January 31 to February 21, 2017 developed issues with their vision during
their recovery period. The issue is isolated to only those patients who
received the combined antibiotic and steroid medication compounded by
one specific Dallas pharmacy during the January 31 – February 21
timeframe. There is no indication that the issue was due to any surgical
Based on Key-Whitman Eye Center’s long history performing successful
cataract surgeries, the issues that these specific cataract patients were
experiencing was extremely unusual and the team took immediate action.
“Our first priority was the wellness of the patients,” said
Jeffrey Whitman, M.D., President and Chief Surgeon at Key-Whitman Eye
Center. “We immediately referred patients showing symptoms to retinal
specialists for examination and treatment at no cost to the patients.
We also notified all patients who had cataract surgery during that time
period of January 31 to February 21, 2017, and requested that they come
in for an examination at no cost to them. Some patients did not experience
any visual acuity issues. For those patients under the care of retinal
specialists, some patients have regained normal - or close to normal -
visual acuity. Others are apparently still experiencing visual impairment.
All surgeons at the PRG Surgery Center who used the locally compounded
medication were advised so that they could notify all affected patients.”
Key-Whitman hired an outside laboratory and a pharmacy expert to investigate,
and the preliminarily findings have just been released. The pharmacy expert
concluded that the compounded antibiotic and steroid medication, which
was prepared by an FDA-inspected laboratory in Dallas and provided to
the PRG Surgery Center during that exact time-period, may not have been
compounded to the specifications represented and may have impacted the
visual acuity of some patients. The investigation continues.
Key-Whitman undertook a comprehensive investigation as soon as the eye
center became aware of this matter. Here is what has been learned to date:
Surgery centers do not make the medicine. It’s made and delivered
pre-packaged by a compounding pharmacy.
- The visual acuity issue is not caused by any bacteria.
- The laboratory testing and analysis performed indicate that the medicine
that was compounded may be out of specifications and was not as represented
- The issue is isolated to only those patients who received the combined
antibiotic and steroid medication compounded by one specific Dallas pharmacy
during the January 31 – February 21 timeframe, and to patients that
did develop visual acuity issues.
- There is no indication that the issue was due to any surgical technique.
- Key-Whitman has provided a notice letter to the compounding pharmacy requesting
they address these issues.
- The FDA, with the cooperation of Key-Whitman, is investigating the medication issues.
- Key-Whitman discontinued its use of the locally compounded medication on
February 21, 2017, and experienced no similar issues prior to January
31, 2017 or since February 21, 2017.
“We have never experienced any issues of this nature during our long
history of performing successful cataract procedures,” said Dr.
Whitman. “We are genuinely concerned and saddened that this has
happened and the investigation is ongoing. We are here for our patients
and will continue to keep them posted with additional information. We’ve
been in touch with all affected patients and continue to monitor their
The medication issue is isolated to only one 3-week timeframe: January
31 – February 21, 2017. Key-Whitman no longer uses the medication.
There is no risk of getting this medicine at Key-Whitman before or after
this three-week time period.