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

Model Number	AAB00
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: if implanted; give date: n/a (not applicable).The iol was removed/replaced in the initial surgery.If explanted; give date: n/a (not applicable).The iol was removed/replaced in the initial surgery.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating the johnson & johnson intraocular lens (iol) was inserted in the patient¿s operative eye.There was a tear in the posterior capsule.The doctor determined that the patient¿s capsule would not support the iol and it was removed and replaced with a model za9002 lens which was placed in the sulcus.The wound was enlarged.Reportedly, the patient tolerated the replacement lens well.Thru follow-up the customer explained that the patient had a combination of weak capsule and weak zonules, the doctor struggled trying to get the lens to rotate.They clarified that sutures were not used and a vitrectomy was not required.They also explained the iol did not cause the capsule to break.No further information was provided.
Additional Manufacturer Narrative
Correction: follow-up #1 for mdr 2648035-2021-07074, referenced the investigation results but did not include the narrative.Investigation narrative is as follows: device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and that the lens was received cut in pieces (not all pieces were received), which is consistent with a lens that was handled during removal and replacement.Furthermore, a detached haptic was observed, which can be attributed to handling or the cutting of the lens during removal, and cannot be confirmed to be related to manufacturing.Based on the return condition of the lens, no further evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.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: date returned to manufacturer: february 25, 2021 section d9: returned to manufacturer: yes.Attempts have been made to obtain missing information; however, to date, no response has been received.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: 11182359
• Report Number: 2648035-2021-07074
• Device Sequence Number: 19420652
• Product Code: HQL
• UDI-Device Identifier: 05050474548640
• UDI-Public: (01)05050474548640(17)241102
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 04/20/2021

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: 11/02/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000190
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/17/2021; 04/20/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 04/06/2021; 04/20/2021
• 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: 1MTEC30 LOT# CH13659
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 98