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

Model Number	AAB00
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: n/a (not applicable).The lens remains implanted.(b)(6).(b)(4).Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site as to date it remains implanted.Photos of the implanted lens were provided and they were evaluated.As per johnson & johnson specifications the ''machine lines'' are categorized into five levels.From level 1 to level 3 the machine lines are acceptable.Level 4 and 5 are rejected.Due to the poor resolution of the photos provided, it was not possible to classify the level of the lines observed.The customer's' reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional investigation requests for this order number have been received.Labeling review: the dfu adequately provides instructions and precautions for the proper use and handling of the product.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it and examine the lens optical surfaces for other defects.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the implantation of the aab00 sensar monofocal iol into the patient's operative eye, the surgeon noticed that the lens had rings.Additional information was received and it was learnt that the patient had an unexpected post-op refraction and their vision was (b)(6) 2018.Reportedly, the account commented that the patient's cornea is not fit to go for a secondary surgical intervention; therefore the lens remains implanted.No additional information was provided.
Additional Manufacturer Narrative
Additional info: additional information was received and it was learnt that the best corrected visual acuity (bcva) pre-op was 0.16 and bcva post-op was 0.4.No out of ordinary medications were given to the patient.Reportedly, the surgeon is planning to implant a symfony intraocular lens (iol) into the other eye of the patient.No further information was provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-(b)(4).

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8046885
• Report Number: 2648035-2018-01443
• Device Sequence Number: 13904896
• Product Code: HQL
• UDI-Device Identifier: 05050474548565
• UDI-Public: (01)05050474548565(17)210713
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 01/01/2005

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 10/25/2020
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/19/2018; 11/04/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005