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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: information unknown/not provided.Section b3: date of event: unknown/not provided.Section d6a: if implanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.Section d6b: if explanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.Section e1: telephone number: (b)(6).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed one similar complaint for this production order number and the issue could not be confirmed as related to manufacturing.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a monofocal intraocular lens (iol) was warped.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that the suspect product expired on aug 15, 2022 and the complaint was received, sep 3, 2024.Additional verbiage for device evaluation and the code of h6: 1670 was in advertently not included on the initial mdr manufacturer report number 3012236936-2024-0002642, therefore, is being captured in this supplemental report.The serial number shipping history for this serial number was reviewed and the product was delivered to the complaint customer on may 18, 2018, prior to the august 15, 2022, expiration date.Per a subject matter expert (sme), our iols are subjected to rigorous preclinical and clinical testing according to international standards, however, they have not been tested past the labeled expiration date.Therefore, the safety and effectiveness of an expired lens is unknown.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: 20318772
• Report Number: 3012236936-2024-000264
• Device Sequence Number: 12677585
• Product Code: HQL
• UDI-Device Identifier: 05050474502123
• UDI-Public: (01)05050474502123(17)220815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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 Expiration Date: 08/15/2022
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2017
• 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