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This report is to bring to the attention with the fda what as the surgeon i believe to be a major oversight and potentially coverup on the part of uspi and alcon.As you can see from below communication, i brought the issue both to uspi and alcon numerous times.It has come to my attention that to this date despite 5 months passing, no substantive investigation has occurred as to the origin of these fragments.I have concern these fragments may represent plastic from alcon phaco packs.Glass introduced into the bottle by unfiltered needles when adding epinephrine could also be the source of the fragments.I have two patients with iris defects due to the projectile fragments.I have real concern this is continuing to occur and indeed a similar report of a clear fragment introduced during phaco was witnessed by (b)(6), the sight sciences rep.At the facility he witnessed (b)(6) pull a similar fragment out of an eye at a neighboring uspi facility, (b)(6) surgery center.I was told by (b)(6), that witnessed the event, that dr.(b)(6) informed everyone at the center what happened.(b)(6) does not have any further feedback beyond that.I wrote dr.(b)(6) last week by email to inquire but have yet to receive a response.(b)(6) is aware of this investigation and is willing to act as a witness if the fda desires to inquire with him.As i currently am using numerous alcon phaco packs a week i reached out to alcon to determine the results of the investigation.Initially i was told by (b)(6) and (b)(6) that an investigation had been completed by alcon.As i continued to press for the name of the person eventually (b)(6) indicated that no investigation had been done but instead he simply wrote an email address on a sterile gown pull card.He did not tell me who he provided it to.I have not heard from (b)(6) or alcon as to why the deception occurred.I have summarized all salient facts and information below.On (b)(6) 2022, i let (b)(6) know of the material i pulled and the submission to pathology.On (b)(6) 2022, i received the anatomic pathology report, which stated that the fragment was a "minute fragment of birefringement material." on (b)(6) 2022, i emailed( b)(6) stating: the material submitted to pathology was not a piece of lens but was synthetic.It could not be divided with forcep and looked like glass.I but also could be plastic fragment from phaco.We need to figure out what the cause is.This is incredibly important for me and all cataract surgeons.Please bring this to senior clinical leadership as this is a significant issue that must be urgently sorted.On (b)(6) 2022, (b)(6) emailed me stating that he was investigating the matter.On (b)(6) 2022, i emailed (b)(6) stating: (b)(6) i think we need a deep dive on the [material pulled on (b)(6) as] glass.I really think something is going on.I think sterile processing is worth exploring for sources of glass or maybe it is from epi bottle.I would observe how the bags are made and ensure no change introduction then.I do strongly believe glass is being introduced.On (b)(6) 2022, as i had forewarned (and feared), due to (b)(6) rsc's, and uspi's blatant failure to heed my admonitions and warnings, i found three pieces of glass/hard plastic in patients' eyes.Fortunately, during the phacoemulsification of three of my patients, (b)(6) who was the operating room registered nurse for the operation, took the following pictures of the video of the operating microscope.She texeted them to me that day: on (b)(6) 2022, i sent two fragments to diagnostic pathology medical group, inc.So an anatomic pathology report could be done on the material.The third fragment, when attempting to verify that this was not human tissue, could not be divided with forceps and it shot away.I made sure we had at least two saved specimens before doing this that day as i had lost previous pieces i had recovered trying to bisect.On (b)(6) 2022, i emailed (b)(6) a senior refractive account manager for alcon, the following: dear all, very serious issue.Three more fragments found in eyes today.(b)(6) is aware and (b)(6) from alcon was able to witness the pieces.I have included here.He thought they looked more like clear plastic and could see when magnified they are milled.I have been seeing these sporadically for a month.As not my asc i can't guide investigation but this needs to be a top priority.At this point i have brought these fragments to everyone's attention, the rsc crew has been aware of the issue for one month.I can't keep pulling these out of eyes.[pictures texted to me by (b)(6) on (b)(6) 2022, i sent the fragment from the operation above to diagnostic pathology medical group, inc.So an anatomic pathology report could be done on the material.On (b)(6) 2022, i received the anatomic pathology report for the material above.The pathology report stated: diagnosis: foreign body, right eye, glass removal: foreign body, as described below; single 0.1 x less than 0.1 x less than 0.1 cm irregular clear material, consisting of glass.Final diagnosis on (b)(6) 2022 by (b)(6) m.D.On (b)(6) 2022, due to rsc's, uspi's, and (b)(6) absolute failure to address almost every issue i raised with him, including, but not limited to, the glass/plastic being found in almost half a dozen eyes at rsc, i reported rsc to the joint commission on accreditation of healthcare ("jcaho").In addition to reporting rsc to jcaho, i also released all my blocks at rsc.On (b)(6) 2022, (b)(6) contacted the company that created the anatomic pathology report immediately above asking if they test for visco fibers.Dr.(b)(6) m.D., the doctor who created the anatomic pathology report above ¿ had her staff pull the specimen and personally examined it, confirming the glass like appearance of the specimen.Dr.(b)(6) then called (b)(6) and told her that the specimen was definitely not fibers.(b)(6) then requested that dr.(b)(6) send the specimen for sectioning but dr.(b)(6) refused as she did not believe the specimen was sectionable.Dr.(b)(6) states that she received "immense pressure" to call the material "fibers".On (b)(6) 2022, (b)(6) emailed dr.(b)(6) directly stating: hello dr.(b)(6) i have 2 emails in regards to hard fibers found in the eye.One deals with provisc.The scan does cut off some of the article.I was not able to download, but at the end speaks of the wood/cellulose component.I hope these help.On (b)(6) 2022, (b)(6) contacted the company that created the anatomic pathology report about testing for duovisc.Dr.(b)(6) talked to (b)(6) again and informed (b)(6) that the specimen was definitely not fibers.Dr.(b)(6) then requested that (b)(6) send a sample of duovisc for comparison.On (b)(6) 2022, dr.(b)(6) had her staff pull both (b)(6) 2022 specimens for comparison and reconfirmed that they were not fibers and were definitely foreign material.Ref report: mw5117750.
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