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); Hemorrhage/Bleeding (1888)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

No sample or confirmed lot number information has been received by manufacturing for evaluation.Two possible lot numbers have been 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.The manufacturer internal reference number is: (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 patient symptoms took one post-operative day to occur.Treatment in the form of a vitrectomy was performed on (b)(6)2020.Hypopyon and fundus hemorrhage was observed on (b)(6) 2020.An additional vitrectomy was performed on (b)(6) 2020.Bacterial cultures have been performed, but the results are not yet available.The patient's symptoms are reported as continuing.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received clarifying that in order to protect the patient¿s corneal endothelium during surgery, soft shell technique was performed before/during ultrasound mode.The patient¿s iris was thin and the iris incarceration in the side port and wound was observed such as intraoperative floppy iris syndrome (ifis).When the surgery was completed, a small amount of viscoelastic remained to resolve iris incarceration in the wound.Upon detection of anterior chamber cells 3+ and fibrin 2+, postoperative infection for this patient was the most severe out of four companion cases.An urgent surgery was performed for anterior chamber irrigation and vitreous surgery.White granular hypopyon and humor vitreus were collected for cultivation test.Haze in the corpus vitreum occurred.It was confirmed that petechial hemorrhage around retina and blood vessel linea alba were slight, but the most severe of the four companion cases.Edema and bleeding in posterior pole were observed.The patient was treated with postoperative eye drops vancomycin plus modacin, and linderon in addition to intravenous first cin and oral administration of predon in 30mg.Since fundus oculi could not be observed and possibility of aggravation in edema and bleeding in posterior pole could not be excluded, the second vitrectomy was performed.Iol and lenticular capsule were removed, and the anterior chamber and vitreum were cleaned.Fibrin adhered to retina was removed.Because corneal edema decreased more than previous surgery and fundus oculi was clearly seen, the remained vitreum was completely removed.Edema and bleeding in posterior pole slightly improved.Upon observation of anterior chamber cells decrease with less flare, decreased bleeding in posterior pole, the patient was discharged with continued treated of vancomycin plus modacin and linderon.Cultivation test results revealed negative for hydatoid bacteria with vitreous humor pseudomonas sp.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 d.10, h.3, h.6 and h.10.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: 10058310
• MDR Text Key: 194787736
• Report Number: 3002037047-2020-00015
• 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
• Is this a Product Problem Report?: No
• 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: 05/14/2020
• 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?: No
• Patient Sequence Number: 1
• Treatment: HYAGUARD.; SANTEN ETERNITY IOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR