MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AR40E
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Reporter email address: unknown/not provided.Reporter telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
The doctor reported their cartridge presented a defect; and when they tried to implant the lens, the handle tore.Lens inserted in the left eye and removed in the same procedure, which caused a delay in the treatment.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since at the time of this investigation, the product has not been received for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.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: based on further review of the complaint file, it was noted that section d10, and section g04 were inadvertently not included on the initial medwatch report.The following sections have been updated accordingly.Section d10, concomitant product: emeraldc cartridge.Section g04, combination product: no.Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on feb 23, 2024.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the lens reveal that it was coated in viscoelastic residue with a detached haptic.The lens was cleaned revealing that the haptic was pulled from the radial hold.Damage was observed on the surface of the lens.Manufacturing site subject matter experts (sme) were contacted regarding the detached haptic; it was determined that the detachment was the result of handling and not a manufacturing defect.The complaint issue "haptic detached" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.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.

• Brand Name: SENSAR IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 12144793
• Report Number: 2648035-2021-08104
• Device Sequence Number: 4259355
• Product Code: HQL
• UDI-Device Identifier: 05050474501980
• UDI-Public: (01)05050474501980(17)250926
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2024

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: 09/26/2025
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 08/13/2021; 04/24/2024
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/08/2021; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC CARTRIDGE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male