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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	04/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional investigation request has been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.The lens remains implanted.(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an aab00 20.0 diopter lens was implanted in the patient's operative eye on (b)(6) 2018.The patient has been diabetic for 20 years, has mild non-proliferative diabetic retinopathy (npdr), and a disc suspect.The following findings were diagnosed at the patient's one day post-operative visit: diffuse iris pigments over the lens anterior surface with in-the-bag iol, a quiet anterior chamber, and best corrected visual acuity (bcva) of 6/9. the following finding were diagnosed at the patient's one month post-operative visit: diffuse iris pigments over the lens anterior surface and a bcva of 6/6.In addition, the patient complained of cloudy vision on this date of service.Visual acuity pre-operatively was (b)(6) and visual acuity one day post-operatively was (b)(6).Furthermore, the patient's one month post-operative visual acuity was 6/6 partial best corrected visual acuity (bcva).Reportedly, the lens remains implanted and there was no patient injury.
Additional Manufacturer Narrative
Additional information was provided by the physician during a medical team discussion and review.The patient was examined (approximate day end of (b)(6) 2018).The physician observed faint pigments over the iol and it¿s not bothering the patient¿s vision.He also notes he has not had any similar occurrences in the past and he is unable to further in investigate the patient as he is not willing for a tuberculosis workup.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7581003
• Report Number: 2648035-2018-00843
• Device Sequence Number: 16639186
• Product Code: HQL
• UDI-Device Identifier: 05050474548664
• UDI-Public: (01)05050474548664(17)220206
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018
• 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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/06/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 08/16/2018
• 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
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005