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

Model Number	AR40E
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter name: unknown, information not provided.Phone number: (b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) could not unfold by itself.The patient underwent cataract surgery and lens implantation due to high myopia and senile cataract.During iol implantation, one side of the haptic could not be unfolded.The lens was removed and replaced with a new one and the implant was completed smoothly.No additional information was provided.
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 records review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that 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
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: 10505246
• Report Number: 2648035-2020-00667
• Device Sequence Number: 5659098
• Product Code: HQL
• UDI-Device Identifier: 05050474501850
• UDI-Public: (01)05050474501850(17)240717
• Combination Product (Y/N): Y
• Initial Reporter Country: CN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 07/17/2024
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00030
• 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: 08/12/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 10/25/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/14/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005