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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
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 aab00 model intraocular lens(iol) was implanted into the eye and was removed in the same surgery because the capsule had a rent.The lens was removed with lens cutters and 10-0 nylon suture was used.Iol was placed same surgery.20.0 a z9002 20.0 diopter lens was in the sulcus in the same surgery.Patient went home without further problems.Additional details received states that incision enlargement was done to accommodate lens cutters and vitrectomy was not performed.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 3/25/2021 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.The lens was cleaned and no cosmetic defects were observed.The complaint issue could not be confirmed 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 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.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the codes 4625 sutures, 4625 incision enlarged, and 4581 incision enlarged was inadvertently not included in section h10.Therefore, it is captured in this supplemental report.Section h6: health effect: impact code: 4625 sutures, 4625 incision enlarged.Section h6: health effect - clinical code: 4581 incision enlarged.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: 11494681
• Report Number: 2648035-2021-07387
• Device Sequence Number: 2965169
• Product Code: HQL
• UDI-Device Identifier: 05050474548695
• UDI-Public: (01)05050474548695(17)240908
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/13/2021; 08/28/2022
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/11/2021; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLATINUM CARTRIDGE LOT#CH14558.; PLATINUM CARTRIDGE LOT#CH14558.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female