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 Code	No Code Available (3191)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye due to an incorrect lens power.There was no vitrectomy, incision enlargement or sutures required.Another lens (same model and dower diopter) was implanted as a replacement.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Corrected data: in the initial mdr, there was a typo of the initial report which states; another lens (same model and dower diopter).It should have stated same model and lower diopter.Additional information: device available for evaluation; returned to manufacturer on: 3/10/2020.Device evaluation: the lens has viscoelastics and what appears to be blood.There is a tear/ cut across the lens.The lens returned conditions are compatible with a lens that has been explanted/removed after insertion; this is consistent with the initial report.Limited information was received regarding the reported incorrect lens power and no further information is available.The customer does not provide information of what may have caused the reason to implant a lens of incorrect power (user/calculation error or product quality deficiency).Customer does indicate the lens replacement model is the same (aab00) and different diopter (14.5).Based on the returned product evaluation and information provided, a product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f 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 nr-0148919 and capa-010215.

• 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: 9753824
• Report Number: 2648035-2020-00178
• Device Sequence Number: 14007377
• Product Code: HQL
• UDI-Device Identifier: 05050474548589
• UDI-Public: (01)05050474548589(17)230614
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 10/25/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/17/2020; 11/02/2020
• 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: 77 YR
• Date Report Sent to FDA: 01/01/2005