MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number 160909000J

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

Patient Problems Endophthalmitis (1835); Hypopyon (1913); Clouding, Central Corneal (2228)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

No sample or confirmed lot number has been received by manufacturing for evaluation.Two possible lot numbers were received.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.(b)(4).

Event Description

A physician reported that a viscoelastic product was used during a cataract surgery after which the patient presented with postoperative endophthalmitis.Additional information has been requested.Additional information received further clarified that the patient's symptoms of hypopyon and vitreous clouding in their right eye first appeared two-days post operatively.Bacterial cultures have been performed, but the results are not yet available.The symptoms were treated by performing a vitrectomy on (b)(6) 2020.The patient's current condition was reported as improving.Additional information received further clarified that the same viscoelastic syringe was used for four patients.

Event Description

Additional information received further clarified that due to corneal edema, information on anterior chamber cells was unknown.As the patient had glaucoma concomitantly which was treated with cosopt and alphagan preoperatively, their intraocular pressure (iop) of 34mmhg was considered high and related to stopping their glaucoma medication.Diamox was prescribed and cosopt and alphagan eye drops were restarted.Slit lamp examination revealed anterior chamber cells of +3 along with fibrin and hypopyon.The patient underwent urgent surgery for anterior chamber irrigation and vitreous surgery.Haze in corpus vitreum occurred.Petechial hemorrhage around the retina and blood vessel linea alba were slightly observed.Additionally, the patient was treated with post-operative eye drops of vancomycin, modacin and linderon.Intravenous chienam with limbeta was administered in addition to oral predonin30mg.The patient was discharged when the anterior chamber cells slightly decreased.Delirium symptoms appeared.At last post-operative follow up, iris pigmentation was noted on the intraocular lens (iol) with no issue with macular form noted.Patient was further treated with rinderon, cravit, bronuck with continuation of cosopt and alphagan.Additional information regarding the bacterial culture tests were received which confirmed the iol was negative, the anterior chamber fluid tested positive for staphylococcus lugdunesis 3+ and the vitreous fluid tested positive for staphylococcus lugdunesis 4+.It was further stated, not only the same type of bacteria were detected from both anterior chamber and vitreous fluid, but also the detected number was large therefore, it was considered staphylococcus lugdunesis was the responsible bacteria that caused the endophthalmitis.

Manufacturer Narrative

Additional information is provided in sections b.5, b.6, b.7, h.3, h.6 and h.10.Samples have been placed in transit to manufacturing which have not yet been received for evaluation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Complaint trending was reviewed for the two potential lot codes provided, 19k04ka and 19j23ma.There were no other similar complaints found for either of the two potential lot codes outside of the related complaints.Batch records were reviewed and all testing results met specifications for both potential lot codes at the time of release.Ten unopened viscoelastic folding boxes with potential lot number 19k04ka and five unopened viscoelastic folding boxes with potential lot number 19j23ma were received as complaint samples.The chemical lab tested the ph and the osmolality of the products and the results are within specifications.Since all initial test results are conforming, no production deviations that could cause the reported defect were reported and the returned samples are conforming for the tested parameters, the complaint could not be confirmed.A root cause cannot be determined.After investigation, we can conclude that the investigated product met specifications at the time of release therefore, a specific corrective action or preventive action cannot be initiated however, further trending is performed.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• MDR Report Key: 10052267
• MDR Text Key: 190815703
• Report Number: 3002037047-2020-00012
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160909000J
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 05/13/2020; 09/28/2020
• Supplement Dates FDA Received: 05/26/2020; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: AMO TORIC IOL.; HYAGUARD.; AMO TORIC IOL; HYAGUARD
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR