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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ethnicity and race: information was asked but was not provided.Date implanted: not applicable, as the iol was removed/replaced during the same procedure.Date explanted: not applicable, as the iol was removed/replaced during the same procedure.Attempts were made to obtain the missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported an intraocular lens (iol) was implanted and removed by the doctor due to a crack in the haptic; iol was replaced with a back-up lens with the same model and diopter size.There was no harm to the patient.Through follow-up, additional information was received confirming no unplanned incision enlargement and no suture(s) required.Patient outcome post-procedure was reported as successful, with no complications, and it took a little bit longer than scheduled.No further information is available.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 28-sep-2021.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed the half of an iol (the other half missing).Viscoelastic residue was found on the optic body and haptic, which is consistent with a lens that was handled during removal.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, 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 specification.No nc/er was found as part of this manufacturing records review.Historical data analysis: a search revealed that no other complaints have been received for this production order (po) number.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 12451842
• Report Number: 2020664-2021-07236
• Device Sequence Number: 14436980
• Product Code: HQL
• UDI-Device Identifier: 05050474635975
• UDI-Public: (01)05050474635975(17)240713
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 12/06/2021

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: 07/13/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• 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: 08/12/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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 Sex: Female
• Patient Weight: 50 KG