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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the patient's cataract surgery, one side of the intraocular lens broke when using an intraocular lens injector to implant the non-preloaded intraocular lens (iol).Removed the damaged intraocular lens through a large incision and replaced the intraocular lens implant.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown/ asked but not available.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.However model is ar40e-21.5.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as serial number was not provided.Section d4: unique device identifier (udi #): unknown, as serial number was not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section e1: initial reporter, name: unknown/not provided.Section e1: initial reporter, email address: unknown/not provided.Section e1: initial reporter, address (state, province, or territory and post office or zip code): unknown/not provided.Section e1: initial reporter, phone number: (b)(6).Section e2: initial reporter, healthcare professional: unknown/not provided.Section e3: initial reporter, occupation: unknown/not provided.Section h3: other 81: the device was 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.Section h4: device manufacture date: unknown as serial number was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received on apr 2, 2024 whereby product was identified to be ar40e, with serial number (b)(6).Therefore, the fields below are being corrected as follows: section d1 - brand name: (b)(6).Section d4 - catalog number: ar40e00215.Section d4 - serial number: (b)(6).Section d4 - expiration date: feb 4, 2028.Section d4 - unique identifier (udi) number: (b)(4).Section h4 - device manufacture date: feb 4, 2023.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 04/12/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found the lens was cut with missing pieces.The lens portion received was cleaned and presented no issues that could have caused or contributed to the complaint event.No further evaluation was performed.Hra (health risk assessment) and human risk factor documents were reviewed for the complaint issue reported.The results of this hra and human risk factors review do not confirm that the above situations occurred during manufacturing, and are only provided for informational purposes; therefore, no further escalations are required.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18378452
• Report Number: 3012236936-2023-03233
• Device Sequence Number: 7722802
• Product Code: HQL
• UDI-Device Identifier: 05050474502130
• UDI-Public: (01)05050474502130(17)280204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

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 Model Number: AR40E
• Device Catalogue Number: AR40E00215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 04/02/2024; 05/22/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 04/22/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Male