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

Model Number	AAB00
Medical Device Problem Codes	Break (1069); Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown, not provided.If implanted; give date: not applicable; lens not implanted.If explanted; give date: not applicable; lens not implanted; therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was a small scuff on the intraocular lens, (iol).The customer indicated that there was possible patient contact; however, there was no reported patient injury.The doctor used a different lens to complete procedure.It was not known when the event occurred, if it was during handling (preparation) or prior to insertion.No further information was provided.
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 (b)(4) and capa-010215.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed 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 & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the device code "1120" was inadvertently entered in the initial emdr report which is incorrect.The correct device code that should have been entered is "1069" which has been listed in this supplemental report.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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9376509
• Report Number: 2648035-2019-01250
• Device Sequence Number: 3012414
• Product Code: HQL
• UDI-Device Identifier: 05050474548633
• UDI-Public: (01)05050474548633(17)230521
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000185
• 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: 11/01/2019
• Supplement Date Received by Manufacturer: 02/09/2020; 02/18/2020; 10/25/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 03/06/2020; 03/09/2020; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005