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

Model Number	AAB00
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.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 the technician had loading issue with the sensar intraocular lens (iol).Upon insertion, the surgeon noticed that the trailing haptic was torn off.Lens was removed and replaced with a back up lens without further incident.Patient outcome was not provided.No further information provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: returned to manufacturer on 1/25/2021.Section h3: device returned to manufacturer? yes.Device evaluation: visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics, a detached haptic.And that the lens was received cut in half.Which is consistent with a lens, that was handled during removal.The dimensional inspection was performed on the remaining haptic and measured within specifications.Based on the return condition of the lens, no further product evaluation could be performed.¿dc-haptic detached¿ was confirmed.However, per the initial report, this issue was observed, while handling for insertion.And therefore, cannot be confirmed to be related to manufacturing.And no product deficiency could be identified.¿dc-loading issues¿ could not be confirmed, because the lens was received outside/without a cartridge tip.And also because the issue was observed, during handling per the initial report.And therefore, cannot be confirmed to be related to manufacturing.And no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed, no other complaints have been received for this production order number.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.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the device problem code 1069 provided on the initial report needs to be corrected.The correct medical device problem codes are updated below.Also, health effect impact code: 2199 needs to be corrected, to 4631 removal and replacement.Fields below updated: section h6: medical device problem code: 1261 for haptic detached.Section h6: medical device problem code:1670 loading issues.Section h6: health effect impact code: 4631 removal and replacement.All pertinent information available to johnson and 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11143984
• Report Number: 2648035-2021-07063
• Device Sequence Number: 631864
• Product Code: HQL
• UDI-Device Identifier: 05050474548671
• UDI-Public: (01)05050474548671(17)240927
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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: 09/27/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/30/2021; 10/18/2022
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 02/26/2021; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2020
• 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 Age: 71 YR
• Patient Sex: Female