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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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| Catalog Number 8065750833 |
| Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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| Patient Problems
Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Capsular Bag Tear (2639); Vitrectomy (2643)
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| Event Date 03/10/2015 |
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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A customer reported to technical services that during a cataract extraction with intraocular lens (iol) implant procedure the system froze.The patient experienced a posterior capsule tear.The surgeon attempted to do an anterior vitrectomy but the vitrector was not cutting.The system was exchanged.The incision was enlarged to place an anterior iol.Some cataract remnants fell to the posterior of the eye.The wound was then sutured and additional glue was applied to close the wound.It was planned to refer patient to retinal specialist.A letter was received from customer stating that he is still experiencing blurriness, watering, night blindness and pain.
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Manufacturer Narrative
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This is a (b)(6) patient who has reported (to the courts) that during the surgery performed on him by a female physician known as dr.(b)(6) the system froze.This resulted in a posterior capsule (pc) tear, and a vitrectomy followed.However, the vitrectomy cutter was not cutting as expected and the case was completed with another console.The patient was referred to a specialist.The outcome has been listed as ¿blurriness, watering, night blindness, and pain.¿ patients¿ medical history is listed in part of documentation: (non: smoker/non: drinker) arthritis, benign localized hyperplasia of prostate with urinary obstruction and other lower urinary tract symptoms, cataract bilateral, chronic rhinitis since 2011, depression, degenerative joint disease, erectile dysfunction, heartburn, hyperlipidemia, hypertension, obstructive sleep apnea, ptsd (post-traumatic stress disorder) surgical report per the surgeon¿s dictation: date of surgery was listed as (b)(6) 2015.The pre-operative diagnosis was listed as ¿visually significant nuclear sclerotic cataract (os)left eye.¿ the procedure indicates phacoemulsification with stable anterior chamber intraocular lens implant (iol) and unstable sulcus iol intraocular lens placement (os) left eye.The complications were listed as having to require an anterior vitrectomy, (retina specialist referred).The lens implant was listed as model mta 4uo, 16.5 diopters (d).The sulcus was listed as unstable.However, the iol was placed in the sulcus.The patient was positively identified by me and brought back to the operating room in the supine position.The patients¿ chart reviewed to verify the correct lens and power.Proparacaine was administered to operative eye followed by betadine.Intravenous anesthesia was administered.Patient was prepped and draped in standard sterile fashion for ophthalmic surgery and a lid speculum was placed in the operative eye.The clear corneal paracentesis incision was created using the sharp point blade.Preservative free lidocaine, followed by viscoelastic was then injected into anterior chamber.A phakokeratome blade was used to create the main clear corneal incision temporally.A curvilinear capsulorhexis was initiated with a bent cystitome and completed utilizing utrata forceps.Hydrodisection was performed utilizing a balances salt solution (bss) on a 27 gauge cannula until the nucleus was mobilized adequately.The nucleus was partially removed when, (during sculpt) the phaco machine ¿froze,¿ which resulted in posterior capsular tear.Additional viscoelastic was used and then attempt was made to do bimanual vitrectomy but the vitrector was not cutting adequately.The machine was then switched to another machine and some residual nuclear and cortical material was mobilized using manual i/a using simco cannula, phaco incision was extended on each side and sulcus iol was then placed in view of the fact that the anterior capsular support looked ok , first haptic looked ok but the second haptic kept on slipping off the ciliary sulcus despite repeated attempts.Hence decision was made to place anterior chamber iol in view of the sulcus iol being unstable and one haptic which slipped out of the ciliary sulcus towards the end of the case.Some nuclear and cortical material fell into the posterior chamber and some cortical material was remaining in place around 3 and 4 o ¿clock.The cortical remnants were removed using irrigation-aspiration as much as possible.Miostat was used twice during the case.Phaco wound was then extended again.Lens glide was then used to place anterior chamber iol.The viscoelastic was removed via irrigation/aspiration (i/a).Additional bss was irrigated into the anterior chamber.The corneal wounds were hydrated with bss and closed with 2 interrupted 10.0 nylon sutures and additional glue was applied to the wound which was checked for wound leak and no leak was detected.The eye pressure was appropriately soft at the end of the case.Bacitracin ointment was placed on the eye and the eye was shielded.The patient was awakened and was wheeled back to the recovery room in excellent condition.Total operation time was listed at 2 hours and 10 min.The subsequent plan was listed as ¿contacting retina specialist for interval posterior vitrectomy and removal of sulcus iol and creation of iridectomy.The patient tolerated the procedure and was discharged.¿ posterior capsule (pc) tear is a potential consequence of cataract extraction by phacoemulsification.Predisposition to pc tear or zonular dehiscence can be influenced by many factors including, but not limited to, congenital posterior lenticonus, posterior sub capsular (psc) cataract, poor visibility secondary to patients comorbidity [ie.Dense arcus, pterygium, band keratopathy, corneal scars, interstitial keratitis], poor microscope illumination [red reflex], ergonomic obstacles, limited intraocular working space, abnormally long or short axial lengths, pseudoexfoliation, zonular laxity, poor dilation, intraoperative floppy iris syndrome (ifis), dense cataracts, asteroid hyalosis, or inadvertent patient movement.The conditions that increase the risk of pc tear during phacoemulsification include ergonomic obstacles, limited intraocular working space, poor visualization, increased nuclear size and density, weakened zonule, a radial tear in the capsulorhexis, and an inability to rotate the nucleus or epinucleus.These conditions may arise either because of the ocular anatomy, or because of surgical technique.There is no evidence contained within the reported information at this time that indicates that the design or performance of the infiniti vision system had any effect on the integrity of the posterior capsule.The system was examined.The company representative did not mention finding anything with the associated system, that could have contributed to the reported issue.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on may 30, 2006.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported events of system locking and probe performance cannot be determined conclusively.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.(b)(4).
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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A current eye examination report was sent to legal.The doctor's current assessment of the patient indicates that while there is an iris suture present, there is currently no uveitis or ocular cause of chronic pain.Per the surgeon, some patients can develop eye pain following cataract surgery so the eye pain could be related.The patient has experienced diffuse pain around the eye, but specifically to the supraorbital notch, which could suggest trochlear headache.The doctor believes the patient would benefit from a block to the supraorbital notch.The patient will be seen in the pain clinic.An mri was performed and showed no explanation for the eye pain or headache.The patient has also been diagnosed with age related macular degeneration (amd) which accounts for the vision loss (worse in the left eye).An ocular coherent tomography (oct) was performed to rule out wet macular degeneration.Mild subretinal fluid was found (left eye worse).Viteliform material was found under the fovea.A fluorescein angiogram was performed and showed mostly staining.The doctor discussed the patient with retinal specialist who did not feel there was active wet amd but still warranted intravitreal injection therapy.An intravitreal injection was recommended and to follow up in a few weeks.
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Manufacturer Narrative
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This is a (b)(6)year old male patient who has reported (to the courts) that during the surgery performed on him by a female physician.A posterior capsule (pc) tear occurred, and a vitrectomy followed.However, the vitrectomy cutter was not cutting as expected and the case was completed with another console.The patient was referred to a specialist.The outcome has been listed as ¿blurriness, watering, night blindness, and pain.¿ patients¿ medical history is listed in part of documentation: (non: smoker/non: drinker) arthritis, benign localized hyperplasia of prostate with urinary obstruction and other lower urinary tract symptoms, cataract bilateral, chronic rhinitis since (b)(6)2011, depression, degenerative joint disease, erectile dysfunction, heartburn, hyperlipidemia, hypertension, obstructive sleep apnea, ptsd (post-traumatic stress disorder) surgical report per the surgeon¿s dictation: date of surgery was listed as (b)(6)2015.The pre-operative diagnosis was listed as ¿visually significant nuclear sclerotic cataract (os)left eye.¿ the procedure indicates phacoemulsification with stable anterior chamber intraocular lens implant (iol) and unstable sulcus iol intraocular lens placement (os) left eye.The complications were listed as having to require an anterior vitrectomy, (retina specialist referred).The lens implant was listed as model mta 4uo, 16.5 diopters (d).The sulcus was listed as unstable.However, the iol was placed in the sulcus.The patient was positively identified by me and brought back to the operating room in the supine position.The patients¿ chart reviewed to verify the correct lens and power.Properacaine was administered to operative eye followed by betadine.Intravenous anesthesia was administered.Patient was prepped and draped in standard sterile fashion for ophthalmic surgery and a lid speculum was placed in the operative eye.The clear corneal paracentesis incision was created using the sharp point blade.Preservative free lidocaine, followed by viscoelastic was then injected into anterior chamber.A phakokeratome blade was used to create the main clear corneal incision temporally.A curvilinear capsulorhexis was initiated with a bent cystitome and completed utilizing utrata forceps.Hydrodisection was performed utilizing a balances salt solution (bss) on a 27 gauge cannula until the nucleus was mobilized adequately.The nucleus was partially removed when, (during sculpt) the phaco machine ¿froze,¿ which resulted in posterior capsular tear.Additional viscoelastic was used and then attempt was made to do bimanual vitrectomy but the vitrector was not cutting adequately.The machine was then switched to another machine and some residual nuclear and cortical material was mobilized using manual i/a using simco cannula, phaco incision was extended on each side and sulcus iol was then placed in view of the fact that the anterior capsular support looked ok , first haptic looked ok but the second haptic kept on slipping off the ciliary sulcus despite repeated attempts.Hence decision was made to place anterior chamber iol in view of the sulcus iol being unstable and one haptic which slipped out of the ciliary sulcus towards the end of the case.Some nuclear and cortical material fell into the posterior chamber and some cortical material was remaining in place around 3 and 4 o ¿clock.The cortical remnants were removed using irrigation-aspiration as much as possible.Miostat was used twice during the case.Phaco wound was then extended again.Lens glide was then used to place anterior chamber iol.The viscoelastic was removed via irrigation/aspiration (i/a).Additional bss was irrigated into the anterior chamber.The corneal wounds were hydrated with bss and closed with 2 interrupted 10.0 nylon sutures and additional glue was applied to the wound which was checked for wound leak and no leak was detected.The eye pressure was appropriately soft at the end of the case.Bacitracin ointment was placed on the eye and the eye was shielded.The patient was awakened and was wheeled back to the recovery room in excellent condition.Total operation time was listed at 2 hours and 10min.The subsequent plan was listed as ¿contacting retina specialist for interval posterior vitrectomy and removal of sulcus iol and creation of iridectomy.The patient tolerated the procedure and was discharged.¿ posterior capsule (pc) tear is a potential consequence of cataract extraction by phacoemulsification.Predisposition to pc tear or zonular dehiscence can be influenced by many factors including, but not limited to, congenital posterior lenticonus, posterior sub capsular (psc) cataract, poor visibility secondary to patients comorbidity [ie.Dense arcus, pterygium, band keratopathy, corneal scars, interstitial keratitis], poor microscope illumination [red reflex], ergonomic obstacles, limited intraocular working space, abnormally long or short axial lengths, pseudoexfoliation, zonular laxity, poor dilation, intraoperative floppy iris syndrome (ifis), dense cataracts, asteroid hyalosis, or inadvertent patient movement.The conditions that increase the risk of pc tear during phacoemulsification include ergonomic obstacles, limited intraocular working space, poor visualization, increased nuclear size and density, weakened zonule, a radial tear in the capsulorhexis, and an inability to rotate the nucleus or epinucleus.These conditions may arise either because of the ocular anatomy, or because of surgical technique.There is no evidence contained within the reported information at this time that indicates that the design or performance of the system had any effect on the integrity of the posterior capsule.The system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on may 30, 2006.Based on qa assessment, the product met specifications at the time of release.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information has been received by legal.A vitrectomy procedure was performed for the removal of the anterior chamber lens and the posterior chamber lens, a new scleral-fixated posterior chamber lens was inserted.The iris was repaired.Post operative ocular coherence tomography for the left eye was performed and was diagnosed with cystoid macular degeneration.Corneal topography was performed on the left eye with potential visual acuity (pva) at 20/30.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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