MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DIB00
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unknown/no information.If implanted; give date: not applicable as the lens was not implanted.The iol was removed and replaced within the same procedure.If explanted; give date: not applicable as the iol was removed and replaced within the same procedure.Initial reporter first name: unknown/no information provided.Email address: unknown/no information provided.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Customer reported that the product misfired.Thru follow-up they explained that the patient moved.There was no defect with the intraocular lens (iol) and this was not a doctor error.The patient moved and caused the lens to misfire.She confirmed there was no capsule tear, vitrectomy or sutures.Unknown if the iol got damaged but the lens was removed and replaced with a backup.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 1, 2021.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection, of the simplicity handpiece, under magnification revealed viscoelastic residue inside of the cartridge.Further inspection revealed that the cartridge tip was damaged which may have occurred during deployment.Visual inspection, of the iol, under magnification revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and presented with no issues.The complaint issue could not be confirmed.A product quality deficiency could not be determined.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
Upon further review of this event it was determined that this event is no longer reportable.The customer mentioned there was no defect with the lens.Therefore, we can presume the patient¿s unexpected movement contributed to the iol misfiring.This implies there¿s no associated reportable device malfunction.There will no longer be any further reporting under mdr report number 2020664-2021-07628.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12712869
• Report Number: 2020664-2021-07628
• Device Sequence Number: 20291337
• Product Code: HQL
• UDI-Device Identifier: 05050474731530
• UDI-Public: (01)05050474731530(17)240806
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/20/2022

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: 08/06/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 01/19/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/10/2022; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White