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

Model Number	AAB00
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a foreign debris was found in aab00 model intraocular lens(iol) after lens was fully inserted into patient's right eye.Doctor could not remove debris and changed iol.The vent was observed after insertion of lens into patient's eye.Procedure was completed successfully using backup lens of same model and diopter.There was no patient injury and no medical/ surgical interventions such as incision enlargement, vitrectomy or sutures were performed.Patient was doing fine at the time of discharge.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 7/22/2021.Section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the lens was received cut in half (only one half received) and also the alleged foreign material on the lens, which was then forwarded to eag laboratories for further analysis.Per eag laboratories, the particle is identified as polyethylene with an excellent overlap with the reference polyethylene from the eag library, confirming the proposed assignment.The fourier transform infrared (ftir) spectrometer spectrum raw data output file generated by the foreign material from eag laboratories was then compared against the manufacturing process ftir library and yielded two results with at least a 0.90000 correlation.The top hit was ¿290864tyvek lid (cartridges)¿ with a 0.983139 correlation.The complaint issue was confirmed, however both positive hits were evaluated by manufacturing site subject matter expert (sme) who determined that both potential sources of the foreign material were not used or present during the manufacturing of aab00 model lenses, and therefore the complaint issue cannot be confirmed to be related to manufacturing and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional complaints from this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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
• MDR Report Key: 12178511
• Report Number: 2648035-2021-08140
• Device Sequence Number: 11602197
• Product Code: HQL
• UDI-Device Identifier: 05050474548626
• UDI-Public: (01)05050474548626(17)250227
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 02/27/2025
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC CARTRIDGE
• Patient Age: 70 YR