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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information ¿ unknown, not provided.Date of event is unknown.The best estimate time would be in the month of march 2021.Implant date (2021 reports): if implanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.Explant date (2021 reports): if explanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) trailing haptic broke during insertion.The lens was removed from the patient's eye and another lens inserted during the same procedure.There was patient contact, but no injury reported.No additional information provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed one other complaint found as part of this production order, no product was received for either complaints for product evaluation, and therefore the complaint issue could not be confirmed and no product deficiency could be identified.No escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: return to manufacturer: 6/8/2021 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half and two detached haptics, which is consistent with a lens that was handled during removal and replacement.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue was confirmed, but no product deficiency could be identified.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.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: 11720293
• Report Number: 2648035-2021-07634
• Device Sequence Number: 4253979
• Product Code: HQL
• UDI-Device Identifier: 05050474514065
• UDI-Public: (01)05050474514065(17)251114
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2021

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: 11/14/2025
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/14/2021; 06/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/24/2021; 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1