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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted/exchanged from the patient's operative eye due to decrease in distance visual acuity (dva), hyperopic post-operatively.The explanted iol was replaced with another za9003 lens, but higher diopter 19.5.There was no incision enlargement, no vitrectomy, no sutures were required.The patient's pre-op visual acuity (va) 20/30, post-op va 20/50.No other information provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: returned to manufacturer on: aug 27, 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 handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from 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.

• 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: 12316856
• Report Number: 2648035-2021-08307
• Device Sequence Number: 3002181
• Product Code: HQL
• UDI-Device Identifier: 05050474528970
• UDI-Public: (01)05050474528970(17)240430
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030180
• 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: 07/14/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR