MAUDE Adverse Event Report: ALCON-BELGIUM/ ALCON N.V. CELLUGEL; AID, SURGICAL, VISCOELASTIC

Catalog Number 8065183810

Device Problem Detachment Of Device Component (1104)

Patient Problems Eye Injury (1845); Vitreous Floaters (1866); Red Eye(s) (2038); Blurred Vision (2137); Vitreous Hemorrhage (2143); Vitrectomy (2643); No Code Available (3191)

Event Date 01/27/2015

Event Type  Injury  

Event Description

A medical doctor reported that the cannula detached from a viscoelastic syringe while injecting solution into the eye during surgery.The detached cannula pierced the zonules resulting in an aborted procedure.Additional info has been requested.Additional info received from the reporter clarified that the detached cannula destroyed the patient's zonules in her left eye.The case had just begun and while deepening the chamber with cellugel prior to capsulorhexis, the cellugel came out and then suddenly the cannula shot off, circumventing the lens while tearing the nasal zonules and coming to rest behind the lens in the vitreous.The cannula was removed and vitreous was noted to be coming around the intact lens.The capsule was still intact.The case was aborted and the anterior chamber was aspirated free of cellugel and the wound closed.The next day f/u, the cataractous lens was clearly loose and had almost no zonular support.A pars plana vitrectomy with lensectomy is planned.

Manufacturer Narrative

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 info becomes available.(b)(4).

Event Description

Additional information was received via telephone, email follow up and legal documents.Per the reporting doctor, the patient's left eye was no longer eligible to receive the corrective intraocular lens of choice due to the reported event.At day-one postoperative evaluation the patient reported experiencing blurry vision in her left eye however, there was no eye pain to report.The doctor reported that the best corrected visual acuity was 20/200.Surgery was recommended to the patient in order to prevent further loss of vision and possibly improve her vision.Two days after the reported event, follow up evaluation revealed that the left lens was unstable with marked phacodonesis and mild vitreous hemorrhage.The patient was administered anesthetic and taken to the operating room whereby phacofragmentation with lensectomy, 23 gauge pars plana vitrectomy and a peripheral iridectomy was performed.The patient then received a secondary anterior chamber lens implantation.Review of medical records provided by the company legal department indicate that subsequent to the secondary procedure, the patient reported periods of blurry vision with a floater in her left eye with increased eye redness and light sensitivity as well as compromised near vision secondary to wearing glasses.The patient medical records also reflects the patient expressed periods of stable vision with no pain and both alternating happiness and dissatisfaction with her left eye vision outcome.

Manufacturer Narrative

Additional information is provided in event, relevant tests/laboratory data, concomitant medical products and date rec¿d by mfr.No sample was received by manufacturing for evaluation.Investigation showed that no remarks related to this complaint were reported in the batch record filling and visual inspection.All syringes are visually inspected and items with incompletely assembled luer lock adapters (lla) are removed.No loose luer lock adaptors were found for this batch.Previous investigation of similar complaints has been performed by the manufacturer of the syringes.Results of these investigations showed that there were no deviations related to the individual components.Since no complaint sample is available, no further investigation can be done.The root cause is inconclusive as no sample was returned however, customer manipulation is a possibility.Based on the investigation, the potential impact on the market is low therefore, no actions on the market are needed.Complaint trending is performed.

Manufacturer Narrative

Additional information is provided.

Event Description

Additional information was received via legal documents.The patient presented at an eye center that did not perform the initial implantation, complaining of the need to establish care as a new patient.The patient described continuance of foggy symptoms affecting her vision when reading, but with no new or additional symptoms and with no report of any eye pain.Upon a subsequent visit, the patient reported a perceived decrease in her near vision and a concern for glaucoma.During a six-month follow up visit, the patient denied any change to her vision.The patient did complain of frequent very mild aching around her eyes.The patient reported using over the counter drops to treat redness in both eyes.The patient was not using any drops in order to control her intraocular pressure (iop).The patient was assessed for borderline low risk open angle glaucoma however, there was insufficient evidence for treatment at that time.The patient's condition was further reported as stable.

• Brand Name: CELLUGEL
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON-BELGIUM/ ALCON N.V.; medialaan 36 ; vilvoorde B-180 0; BE B-1800
• MDR Report Key: 4548631
• MDR Text Key: 5525158
• Report Number: 3002037047-2015-00044
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P990023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065183810
• Device Lot Number: 14J02E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BETADINE 5%; BSS SOLUTION 500ML; BUPIVACAINE (MARCAINE) 0.75% 20ML INJECTION; CARBACHOL INTRAOCULAR INJECTION 1.55ML; DEXAMETHASONE 0.5ML; LIDOCAINE 2% 50ML; MAXITROL 3.5GM; PREDNISOLONE 1GTT; SODIUM HYALURONATE 0.55ML TOPICAL; TIMOPTIC,; VANCOMYCIN INTRAOCULAR INJECTION; TIMOPTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 61