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

Model Number	ZA9003
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: age or date of birth at time unknown/no information patient weight and ethnicity unknown/no information if implanted; give date n/a (not applicable).The iol was removed/replaced in the initial surgery.If explanted; give date n/a (not applicable).The iol was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating there was debris on the intraocular lens (iol).The iol was fully inserted and removed and replaced during the same procedure.It was indicated that no further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: january 25, 2021 section d9: returned to manufacturer: yes device evaluation: a product quality deficiency could not be determined.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 handled during removal and replacement.Foreign material (multiple dark spots) were observed on the lens.The lens was forwarded to eag laboratories for further analysis.The ftir(fourier transform infrared spectrometer) spectrum raw data output file generated by eag laboratories was then compared against the jnj añasco manufacturing process ftir library and did not yield any results with at least a 0.90000 correlation.The complaint issue was confirmed, however due to the low correlation (correlation less than 0.90000) between the foreign material and the jnj añasco manufacturing process ftir library it cannot be confirmed if the issue is related to handling or manufacturing, because añasco has manufacturing controls in place to prevent the release of product with foreign material on it, and therefore no product deficiency could be identified.The ftir indicates that the red debris is consistent with a protein-containing material (e.G., blood, human albumin).A photograph which accompanied the sample indicated the location of the unknown red material on the surface of an iol.The red material was removed from the iol with a clean, steel surgical blade for analysis.The ftir spectrum of the red debris indicates that the red material is consistent with a protein-containing material (e.G., blood, human albumin) by comparison with references from our library.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints have been received for this production order.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 & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected information: the initial mdr #2648035-2021-07072 captured h6 health effect ¿ impact code as 2199 - no health consequences or impact.Upon further review it was noticed that the iol was fully inserted and then removed.Therefore, the code for h6 health effect ¿ impact code should be 4631 - more complex surgery.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
• MDR Report Key: 11152935
• Report Number: 2648035-2021-07072
• Device Sequence Number: 11732100
• Product Code: HQL
• UDI-Device Identifier: 05050474529069
• UDI-Public: (01)05050474529069(17)230207
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2021

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: 02/07/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 04/02/2021; 04/12/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 04/06/2021; 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD CARTRIDGE