MAUDE Adverse Event Report: AMO(HANGZHOU) CO., LTD. COMPLETE; ACCESSORIES, SOFT LENS PRODUCTS

Model Number 8941X

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

Patient Problem Conjunctivitis (1784)

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, weight, and ethnicity: unknown/no information.Date of event: unknown/no information.Lot number: unknown/not provided.Expiration date: unknown as the serial/lot number was not provided.Unique identifier (udi) number: udi is unknown as lot number is not available.Initial reporter phone number: (b)(6).The telephone number format does not align with the field, therefore it's entered here.The device is not returning for evaluation as indicated by the customer.Therefore, a failure analysis of the complaint device cannot be completed.There was no lot number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

Report received that a patient was diagnosed with allergic conjunctivitis at a routine medical examination after using complete solution.The patient had no subjective symptoms and considered non-serious.The casual relationship between the contact lens and care products is unknown.After discontinuation of prescription 2 week lens, the patient was prescribed 1day.1-2 weeks later, follow-up examination was instructed.The patient was prescribed drug: alesion lx 0.1%.Follow-up visit was on day 28, patient was assessed as recovering.Doctor's comment "2week can be used for improvement of allergic findings.Discontinuation was instructed in the event of exacerbation." no further information was provided.

• Brand Name: COMPLETE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): AMO(HANGZHOU) CO., LTD.; 200, 4th ave. hz e&t dvlp. zone; hangzhou, zhejiang 31001 8; CH 310018
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12670444
• MDR Text Key: 278183765
• Report Number: 2020664-2021-07832
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8941X
• Device Catalogue Number: 93926JA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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