MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TOTALCARE; SOLUTIONS

Model Number 08772X

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

Patient Problems Bacterial Infection (1735); Intraocular Infection (1933)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, was not provided.Date of event: unknown, not provided.Udi #: a completed udi # is unknown.(b)(4).Device evaluation: the consumer did not return the complaint product.Retain testing however, was performed.Retain product testing: retained products were tested using both chemistry and microbiology methods, all results were within specifications, no product failure was confirmed.Manufacturing record review: a review of the records were performed.All testing items were completed and met specifications, including incoming chemical materials testing, primary materials inspection, product physical appearance inspection, bulk and finished product chemical testing and microbial testing, sterilization records, environment monitoring and water system monitoring.There were no non-conformances related to this complaint.In conclusion, reported lot was deemed acceptable for release.Labeling review: a review of the directions for use was performed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no quality product deficiency was identified.The consumer's reported event could not be confirmed.All pertinent information available to abbott medical optics has been submitted.

Event Description

The consumer reported he was unhappy about the working of the new product.He recently had an infection in his eyes and considered the fact that he used the new total cleaner the reason.The total cleaner is not working properly.He concludes that the total care cleaner bottles now contain the totalcare solution product.He concludes this based on the fact you can now put the lens straight in the eye after using the totalcare cleaner.Consumer went to his doctor (general practitioner) and the optician.He received medication and his eyes are now healthy again.But he is not using the product anymore.Additional information was provided.A call was made to the consumer to share the differences between the previous product formula and the new formula and the consumer shared that he believes there is no correlation between the product and the infection he had.There is no worry anymore about the quality of our products.Yet, he finds the old cleaner better.The infection he had was bacterial.He was prescribed 1mg chloramphenicol ointment as a treatment.Eye and eyelids were red with a lot of debris on both eyes but it was not painful.Consumer works in agriculture and, so he works with dangerous or toxic product on a regular basis.His optometrist gave him another cleaner.Both consumer and optometrist did not say the event had something to do with the total care cleaner, they just don¿t know.As consumer works in agriculture they think it was rather due to his work with dangerous goods that he used.No further information was provided.

• Brand Name: TOTALCARE
• Type of Device: SOLUTIONS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 4th ave; hz econ/tech develop. zone; hangzhou 31001 8; CN 310018
• Manufacturer Contact: cathey ozuna ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478372
• MDR Report Key: 6981801
• MDR Text Key: 90394063
• Report Number: 3004178847-2017-00022
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)180922(10)ZB09465
• Combination Product (y/n): N
• PMA/PMN Number: K980775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2018
• Device Model Number: 08772X
• Device Lot Number: ZB09465
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention