MAUDE Adverse Event Report: JOHNSON AND 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	Corneal Edema (1791); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, but the best estimate is between (b)(6) 2017 and (b)(6) 2018.(b)(6).(b)(4).The intraocular lens remains implanted in the patent's eye; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (model aab00 +21.5 diopter) was implanted in the patient's left eye on (b)(6) 2017.Reportedly, the refractive target was missed by +2.0 diopters.No secondary surgical or medical intervention was performed.No further information was provided.
Additional Manufacturer Narrative
Additional info/corrected data: the patient developed a corneal edema in the area of the incision during the initial surgery.Reportedly, at the end of the surgery, the pupil was round and the intraocular lens in the posterior chamber was well placed and centered.This information was known at the time the initial report was submitted, but it was inadvertently not entered in the initial mdr.Therefore added the patient code 1791.Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site as to date 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 intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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.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 AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7433893
• Report Number: 3011852734-2018-00046
• Device Sequence Number: 16529745
• Product Code: HQL
• UDI-Device Identifier: 05050474548695
• UDI-Public: (01)05050474548695(17)201108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 11/08/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/30/2018
• 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