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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cataract operation, the doctor noticed that the haptics were looking ¿funny¿ after deploying the lens into the eye.The lens was fully inserted and then removed during the same surgery.There was a 10 minute delay in the procedure.The incision was enlarged and there was no vitrectomy required.No other patient interventions were mentioned.No further information has been provided.
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(6).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected information: in review, it was noted that the clinical code "4581- incision enlargement" was inadvertently not entered in the initial mdr report which has been captured in this supplemental mdr report.It was also noted that in the initial mdr report, the event was inadvertently also marked as "serious injury" in section "b1, b2 & h11" which is incorrect.The event is only a malfunction; therefore, the information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section h6: health effect - clinical code: 4581- incision enlargement.Additional information: section d9 - device available for evaluation? yes.Section d9 - returned to manufacturer? yes.Section d9 - date returned to manufacturer: 17th december 2021.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handling during removal.A detached haptic was observed which can be attributed to handling during loading and insertion.Based on the return condition of the lens, no further product evaluation could be performed on the lens.Visual inspection, of the handpiece, under magnification revealed viscoelastic residue inside of the cartridge.The external assembly was inspected, and no issues were identified.The handpiece was disassembled, and the assembly was inspected, presenting with no assembly issues.Based on the definition of haptic damaged, the complaint issue could not be confirmed despite "haptic detached" being similar to "haptic damage".No product deficiencies could be identified.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12808011
• Report Number: 2020664-2021-08124
• Device Sequence Number: 4757039
• Product Code: HQL
• UDI-Device Identifier: 05050474558281
• UDI-Public: (01)05050474558281(17)240310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown