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

Model Number	PCB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Inaccurate Delivery (2339); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the exact date of event is unknown, not provided, but the best estimate date is october/ november 2021.Implant date: unknown/ not provided.Explant date: lens remains implanted, therefore not explanted.Telephone number: (b)(6).The lens was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implantation according to the dfu (directions for use), the last push was given and the trailing haptic unfolded and stayed in the cartridge.The haptic was not folded on the optic of the lens and the doctors got it out of the cartridge without damage, requiring a secondary tool to free the lens.There was a delay in procedure; however, no patient issues reported and no medical or surgical interventions required.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that h6: type of investigation code (method code) of 4117 (remains implanted) reported in the initial report no longer applies as product investigation results completed appear to indicate that the lens was not implanted as there were pieces remaining in the cartridge.Therefore, correction needed to choose most appropriate code of h6: health effect impact code: 4627 which indicates that product was removed.This report is submitted to correct the initial report 4117 code and field below updated.H6: health effect impact code: 4627.Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 29th january 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue inside of the cartridge.Further inspection revealed a portion of lens received stuck inside of the cartridge and partially overridden by the plunger rod.The handpiece was disassembled and the assembly was inspected, presenting with no issues.The iol was removed from the cartridge, presenting with a portion of detached haptic and lens damage.The complaint issues could not be confirmed, and no product deficiency could be identified.All pertinent information available to johnson and 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13091098
• Report Number: 3012236936-2021-00325
• Device Sequence Number: 4192603
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)240223
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: 02/23/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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