MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AAB00
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: unknown / not provided.Best estimate date is between 1/27/2017-2/16/2017.Manufacturer: device was manufactured at the kulim site in malaysia; however, this site has been closed.Reporter telephone number: (b)(6).The intraocular lens (iol) has not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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 there was a mechanical complication with an intraocular lens (iol).A picture was provided and it looks like the iol is located too near the iris.Through follow up, it was learned that the device was implanted in 2017 in the right eye and explanted and replaced with another johnson & johnson iol (zct225 model and 27.5 diopter) the following month.The surgeon implanted the lens into the capsular bag according to protocol.The cause for the lens being too close to the iris is idiopathic.Pre-operative (op) anterior chamber depth r/l 2.19 axis length r 20.73 l 20.79.The patient was myopic although emmetropia was desired r -1,00 sph -0,50 cyl.145a v0,8.The patient had the following procedures in the right eye: orbicularis resection (2016), yag-ie (06 february 2017).No further details were provided.
Additional Manufacturer Narrative
Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was not returned for evaluation; however, a picture provided by the customer was assessed.The picture shows an anterior segment optical coherence tomography(oct) image of a pseudophakic eye claimed to be implanted with a one piece acrylic sensar monofocal iol model aab00.The labeled picture shows an anterior segment oct image of a pseudophakic eye that was observed compatible with positive vitreous pressure displacing the lens forward to the posterior surface of the iris.Although there is a history of yttrium aluminium garnet (yag) laser capsulotomy 5 year prior, a definitive root cause of the observation cannot be determined from a picture assessment.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine, california 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15442781
• Report Number: 3012236936-2022-02336
• Device Sequence Number: 5595232
• Product Code: HQL
• UDI-Device Identifier: 05050474548718
• UDI-Public: (01)05050474548718(17)201212
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male