MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS

Model Number	AR40M
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was confirmed that the expiration date for this device is 7/11/2019.The device was used beyond its expiration dating.If explanted; give date: not applicable, lens remains implanted.Initial reporter first and last name: unknown.Initial reporter phone number: (b)(6).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: 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 and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a patient underwent left eye cataract surgery with an intraocular lens implanted on (b)(6) 2020.After operation, the eyes were covered routinely.One day after operation, the follow-up was observed: left eye: 0.6 -, conjunctival congestion +, corneal edema +, anterior chamber often deep, tyn (+ +), intraocular lens position was positive, other examination conditions were the same as those in hospital.Patient had inflammatory reaction.The patient was prescribed with: prednisolone acetate eye drops, tobramycin dexamethasone eye drops, moxifloxacin hydrochloride eye drops, compound tropicamide eye drops, and azithromycin dispersible tablets 0.5g, were given to the left eye once every hour.Tobramycin dexamethasone eye drops, moxifloxacin hydrochloride eye drops, compound tropicamide eye drops, and azithromycin dispersible tablets 0.5g, once a day.The second day after operation, the left eye was reexamined: 0.6 +, intraocular pressure: 11.7mmhg, the rest of the examination conditions were the same as before, all improved, the patient was instructed to continue to use the above eye fluid.Patient was discharged.Outpatient review last monday of the surgery period.No further information was provided.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10955632
• Report Number: 2648035-2020-00912
• Device Sequence Number: 14339688
• Product Code: HQL
• UDI-Device Identifier: 05050474514218
• UDI-Public: (01)05050474514218(17)190711
• Combination Product (Y/N): Y
• Initial Reporter Country: CN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2019
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2020
• Initial Report FDA Received Date: 12/05/2020
• 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: Required Intervention
• Patient Age: 75 YR