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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It has been reported that an intraocular lens (iol) is defective, no more details.Unknown if patient contact.No patient injury has been reported so far.No further information has been provided.
Additional Manufacturer Narrative
Corrected data, in review, it was noted that section 'd1, d2 & e3' of the initial mdr were inadvertently populated with incorrect information.The information had been corrected in this supplemental mdr and the following fields were updated accordingly: section d1: tecnis iol section d2: intraocular lens section e3: non-healthcare professional additional information: section d9.Device available for evaluation? yes returned to manufacturer: yes date returned to manufacturer: august 27, 2021 device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptic.The lens was cleaned, and no cosmetic issues were identified.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing records review the manufacturing records for the intraocular lens were reviewed and no non-conformance report was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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
• MDR Report Key: 12185920
• Report Number: 2648035-2021-08170
• Device Sequence Number: 1622103
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)231012
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 10/12/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 10/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1