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

Model Number	AAB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Section d6b: explant date: not applicable, as lens remains implanted.Section e1: email address: unknown/not provided, as information was asked but it was not provided.Section e1: initial reporter telephone number: (b)(6).Section h6: medical device problem code - 3191: no code available (lathe lines).Device evaluation: the product was not returned to the manufacturing site for evaluation; however, a photograph was provided by the customer.Based on the intensity that can be observed on the image provided, the depth of the lines can be observed.A failure investigation was completed and investigation findings concluded that the image provided indicates that the reported lathe lines are considered out of specification, and the failure was attributed to operator error.Therefore, the complaint issue reported was confirmed as manufacturing related.A review of bounding confirmed that there were no additional units affected for similar issues.Conclusion: based on the records reviewed, the risk assessment performed and the current probability of occurrence, this issue is being evaluated as part of continuous improvement project.An awareness was conducted to all personnel involved in manufacturing of the reported complaint product to reinforce the visual inspection during the manufacturing process, to prevent recurrence.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implanting the intraocular lens (iol) into the patient's eye, doctor observed a diffractive ring on the surface of the iol.There is no impact to patient.The lens remains implanted.No further information available.

• 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: 16770707
• Report Number: 3012236936-2023-00895
• Device Sequence Number: 3139279
• Product Code: HQL
• UDI-Device Identifier: 05050474548640
• UDI-Public: (01)05050474548640(17)260222
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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: 02/22/2026
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000190
• 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: 03/22/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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 Sex: Unknown