MAUDE Adverse Event Report: AMO(HANGZHOU) CO., LTD. BLINK CONTACTS LUBRICATING EYE DROPS; REWETTERS

Model Number 09464X

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

Patient Problems Hyperemia (1904); Inflammation (1932)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Age/date of birth, weight and ethnicity: unknown/ not provided.Lot number: unknown, as the lot number provided was invalid.Expiration date: unknown, as the lot number provided was invalid.Udi number: udi number is unknown, as the lot number provided was invalid.Initial reporter telephone number: (b)(6).Telephone number: (b)(6).Manufacture date: unknown, as the lot number provided is invalid.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a consumer experienced red-eyes after using blink contacts.Through follow-up it was learned the consumer sought medical attention and was diagnosed with inflammation.Doctor prescribed anti-inflammatory eye drops.At the time of follow-up the patient's eyes are still red and they have not recovered.No further information provided.

Manufacturer Narrative

Additional information: the lot number: (zs06086) initially provided was invalid, although zs06086 was confirmed as an invalid lot per our service applications and products (sap) system, the manufacturing-investigation site used zh06086 as the suspect lot number and performed review of the manufacturing records and complaint history review.Based on this activity, the following data is being provided on the determined lot number.Section d4: lot number: zh06086, expiration date: 08/27/2022, udi number: (b)(4), section h4: device manufacture date: 08/28/2020.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the determined suspect lot number: zh06086 was a packaging lot, its filling lot: zh06085 and compounding lot: zh06084 were manufactured in aug 2020.All the records for production process were found to be acceptable, 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 was no non-conformance related to this complaint.In conclusion, reported lot was deemed acceptable for release per material and products releasing management procedure a complaint history review found this file to be the only one entered in the complaint system with the invalid initially reported lot number: zs06086.For the investigated lot number: zh06086, no complaints were reported in the previous 12 months.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: BLINK CONTACTS LUBRICATING EYE DROPS
• Type of Device: REWETTERS
• Manufacturer (Section D): AMO(HANGZHOU) CO., LTD.; 200, 4th ave. hz e&t dvlp. zone; hangzhou, zhejiang 31001 8; CH 310018
• MDR Report Key: 11604858
• MDR Text Key: 243474650
• Report Number: 3004178847-2021-07006
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: K040839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/27/2022
• Device Model Number: 09464X
• Device Catalogue Number: 90222CH
• Device Lot Number: ZH06086
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention