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

Model Number	DCB00
Medical Device Problem Codes	Inaccurate Delivery (2339); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight: unknown, information not provided.If implanted, give date: not applicable, as lens was removed during the same procedure.If explanted, give date: not applicable, as lens was removed during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that the preloaded device was defective and was not used.Additional information received revealed that when surgeon advanced the intraocular lens (iol), it advanced sideways onto the lens injector, causing the lens to actually tear.It was stated that only the cartridge tip made contact with the patient's right eye.The surgeon had to manually insert a lens with a surgical instrument.It was indicated that the lens was fully inserted.There was no patient injury reported.No further information was available.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.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
Section d9: device available for evaluation: yes section d9: returned to manufacturer on: oct 4, 2021 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification, of the lens, revealed a lens received in the sterilization pouch with viscoelastic residue on the optic body and haptics.The lens was cleaned and, lens damage and a torn optic body were observed.The received handpiece was visually inspected under magnification which revealed trace amounts viscoelastic residue inside of the cartridge.The lens module/cartridge assembly was inspected and no issues were identified.The cartridge was inspected and cartridge tip damage/broken as well as cartridge damage was observed.No further issues were identified.The complaint issue delivery issue could not be confirmed.The complaint issue iol torn can be confirmed; however, this may be attributed to an inadequate amount of ovd used during implantation, suggested by the trace amounts of viscoelastic residue inside of the cartridge, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.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.

• 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: 12479076
• Report Number: 2020664-2021-07426
• Device Sequence Number: 19795432
• Product Code: HQL
• UDI-Device Identifier: 05050474635791
• UDI-Public: (01)05050474635791(17)240428
• 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): 12/22/2021

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: 04/28/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 11/23/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 09/24/2021; 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: White