MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON DUET; OVDS

Model Number	10-2200-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the product is not implantable.If explanted, give date: not applicable, as the product is not implantable.Attempts have been made to obtain missing information; but no further information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that the doctor ''had a about 3 patients with toxic anterior segment syndrome (tass) on (b)(6) 2018.It was later confirmed that at least 1 patient was affected.In addition, the doctor believes the healon duet may not have caused or contributed to the tass.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the complaint sample was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Although, the actual product that was used was not returned, the account returned an unopened product.Chemical tests for ph, particles, osmolality and viscosity and microbiological test for bacterial endotoxins were conducted on the unopened product received.The results were within product quality specification for healon 10 mg/ml and at the same level as the time for release.Retained product evaluation: visual inspection on retained products was performed.Forty-eight samples were investigated.No visible defects were found on the package or solution.The solution was clear and colorless.No visible defects on the product box.The printing on the carton and labels are correct.All components were included in the product without defects.Product deficiency was not found on retain samples.Product deficiency was not found on the retain samples.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed that no previous complaints on this lot have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON DUET
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7431538
• Report Number: 3004750704-2018-00029
• Device Sequence Number: 1544219
• Product Code: LZP
• UDI-Device Identifier: 05050474573574
• UDI-Public: (01)05050474573574(17)190630(10)UC32018
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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
• Operator of Device: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: 10-2200-10
• Device Catalogue Number: 10290080
• Device Lot Number: UC32018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 04/14/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other