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	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6b: explant date: not applicable, as lens remains implanted section e1: telephone number: (b)(6).Section h6: medical device problem code - 3191: no code available (lathe lines) device evaluation: a usb stick was received and the video provided by the customer displayed an implanted lens.A central ring was observed on the optic body of the lens.The complaint issue "lathe lines" was identified during video evaluation.Each johnson and johnson 1-piece acrylic intraocular lens (iol) is individually cryo-lathed.Due to this process, concentric ring pattern lines may be present on the iol surface.These lines are partially removed in further manufacturing process steps.Before release, an individual and rigorous visual inspection is performed to all our intraocular lenses to determine the presence of surface anomalies that could impact the optical quality of the iol.In addition, all the lenses are individually tested using standardized methodology to evaluate their image quality.The presence of the lens surface lines that were describes is considered a cosmetic observation that based on investigation results do not affect the optical properties and image quality of the iol.Based on the complaint investigation results, a product deficiency/product malfunction could be identified.A failure investigation was initiated to further investigate the central ring observed on the optic body of the lens.The failure investigation found that based on the video there is a cosmetic defect observed on the lens; however, since the lens was not available for evaluation, it was not possible to confirm if this was a lathe line or other cosmetic defect.Manufacturing record review: the manufacturing records for the iol were reviewed.The product was manufactured according to specifications.A search of complaints related to the associated production order (po) was performed.The search revealed that no similar complaint has been received for this po.Conclusion: although a definitive root cause has not been confirmed at this time, johnson & johnson surgical vision, inc.Will continue to monitor these types of events.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the monofocal intraocular lens (iol) resembles a vivity (with a circle in the center), the lens has a flat paracentral circular structure.Account indicated that the lens remains implanted because the patient has no impairments/restrictions.Visual acuity sc and cc + refraction pre-op +0.25sph -1.25cyl 49°a vcc 0.50.Visual acuity sc and cc + refraction post-op.1 opk (28.06): os +0.25sph -0.50cyl.67°a vcc 1.0.2 opk (01.07): no residual refraction assumed.Vsc 0.80.No further information was provided.

• 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: 20378052
• Report Number: 3012236936-2024-000264
• Device Sequence Number: 11684830
• Product Code: HQL
• UDI-Device Identifier: 05050474548596
• UDI-Public: (01)05050474548596(17)270503
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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: AAB00
• Device Catalogue Number: AAB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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 Sex: Female