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

Model Number	DFR00V
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during product handling and prior to insertion the pre-loaded intraocular lens (iol), the lens was stuck in the cartridge and haptic was getting crushed; there was no patient contact.Through follow-up, additional information was received stating the lens and/or haptics was damaged in the pre-loaded device prior to patient contact and the same model and diopter backup lens was used with no issues.No further information is available.
Additional Manufacturer Narrative
Patient age/date of birth, patient weight, and ethnicity and race: not applicable as there was no patient contact.Date of event: unknown as information was not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.The device was not returned for analysis therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Product investigation was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 01-dec-2021.Section h-3: device returned to manufacturer: yes.Device evaluation: visual inspection under magnification revealed a simplicity cartridge without viscoelastic residue inside of it.Further inspection revealed a lens overridden and stuck inside of the cartridge.The handpiece was disassembled, and the assembly was inspected, presenting with no cosmetic issues.The lens was removed from the cartridge, but it was damaged in the process.The lens was cleaned and presented with damage to the optic body.The complaint issue haptic damaged could not be confirmed.The complaint issues stuck in cartridge and lens damaged could be confirmed; however, they may be attribute to an inadequate amount of ovd used, suggested by the lack of viscoelastic residue inside of the cartridge, and the process of removing the lens from the cartridge, respectively, and cannot be confirmed to be related to a manufacturing issue.Therefore, 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.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that initial report of conclusion code 67 in investigation conclusion was incorrect.Correct conclusion code must be 4315.Field below updated to correct code initially reported.H6: investigation conclusion: 4315 (caused not established).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 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 ; 1700 e. st. andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12776052
• Report Number: 2020664-2021-08054
• Device Sequence Number: 20318951
• Product Code: HQL
• UDI-Device Identifier: 05050474750791
• UDI-Public: (01)05050474750791(17)240613
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2022

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: 06/13/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 01/20/2022; 05/16/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 01/28/2022; 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2021
• 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: Unknown